SRS 20/II - Greiner Bio
Contents
1. 25 SRS 20 11 USER MANUAL page 3 of 37 VACUETTE o aA one step ahead 9 TROUBLESHOOTING GUIDE 0s200200000200000n00200000n0000000002001002000 ooieoe ioios da pioco oboea tseo sesto sees snae to sene SOSE enses snae 26 10 TECHNICAL SPECIFICATION SRS 20 II ussnssnssonsonssnssnesnsnnsonssnssonsnnsonsnnsnnsnnsnnssnssnnsnnssnsnnnansnnssnsnnsonsnnssnsnnsnnnenn 28 11 PACKAGING INFORMATION 2ussurs0rsossnsonsssssnssnssonsnnsnnsnnsnnsnnssnnsnnsnnsonsnnsnnsnnssnsnnssnssnnsnnsnnsnnsnnssnnsnnsonsnnsnnsnnssnnsnn 30 P Wu d UI DJ b AA 31 As THEORETICAL INFORMATION 22004282 31 A l ATIS PUT M 31 A 2 Variations of ESR D M 31 B PRINTER TYPES PROTOCOL DESCRIPTION nennen trennen reet nest eren ren VWS Vivvo s Teruk 33 C HOST CONNECTION PROTOCOL tpe veceususuteonevestsonsvantest ons 34 SRS 20 11 USER MANUAL page 4 of 37 VACUETTE nucum one step ahead 1 INTRODUCTION 1 1 Intended use The SRS 20 Il ESR analyzer is an automatic instrument controlled by a microprocessor and exclusively employed for the in vitro diagnostic determination IVD of erythrocyte sedimentation rate ESR It constantly and simultaneously scans 20 test tubes which are custom made for ESR analysis The SRS 20 Il follows the sedimentation of each sample independently memorizing levels for the whole period of analysis2. The results memory can save 500 results When the capacity is exceeded this is indicated on Ham the screen with memory full Pushing CANC key ugue EIE i i does not cancel the memory it just deactivates the maus EB menor Full signal If necessary the user must cancel the results SCC memory In any case any further result can only be saved if the previously stored data is erased E EDIT Modification of data in the results memory With this function data from the memory can be MEMORY Ex H C ABZ H C AGF H ROME Eras M Bos n 12 visualized and modifications can be made With the Cees M D arrow keys it is possible to shift the cursor in the kage N 612345678901 memory The arrow key left and arrow key right allow EBST N mn d mm the shift of one page at a time in order to quicken the movement operations By pushing the ENT key it is possible to modify the values relating to the results or to cancel possible mistakes which the instrument has detected 5 3 QC Function 3 General information The instrument has a complete quality control pH se in 2h t vef ESTE management system so that the user can be assured y Boooo goood y of correct reader functioning and calculations Hooooo BBBBDH i Theoretical values of control samples can be inserted E dHHHH BEBBBE to activate control reading via their identification to 238888 888852
3. gt VACUETTE greiner bio one CE Sed Rate Screener 20 11 SRS 20 11 including Software G2P120BO Vers 1 2 ESR Analyzer USER S MANUAL MAN 002 Revision 8 Revision date November 30 2012 VACUETTE um one step ahead This user manual follows the directions as prescribed by the CEN TC 140 recommendations for in vitro diagnostic instruments EN ISO 18113 3 2009 INSTRUMENT NAME Sed Rate Screener 20 II SRS 20 11 including Software G2P120BO Vers 1 2 Short cut name SRS 20 ll Automatic Sed Rate analyzer 20 measuring channels Greiner Bio One GmbH Bad Haller StraBe 32 A 4550 Kremsm nster AUSTRIA Tel 43 0 7583 6791 0 Fax 43 0 7583 6318 Mail office at gbo com PLEASE READ THIS ENTIRE PRODUCT MANUAL BEFORE USING THE INSTRUMENT FOR THE FIRST TIME SRS 20 II USER MANUAL page 2 of 37 VACUETTE nucum gt one step ahead CONTENTS 1 INTRODUCTION N 5 T INTENDED USE ote erbe e E cer ee e Oe te ce WO e RO eU OVE EE EU ES 5 2 POTENTIAL DANGERS AND SAFETY PRECAUTIONS 222202000000000000000000200000000000020000000000000 0000000000000 0000000 5 2 1 USER PRECAUTIONS csi ad Fee CEDE EE ER rear 5 2 1 1 User Ident fication A 5 2 2 ELECTRICAL EQUIPMENT E 5 2 3 MECHANICAL EQUIPMENT ccccecssssseecececeesessnaeceeececsesnaecceceesceeseseaeseceesceesnaaeceesecesessuaeseceseussa
4. 5 The 2 row values depends on the internal instrument temperature The table below must be used to get the reference values for the 2 row Look at the column where your internal instrument temperature is included within a specified range SRS 20 11 USER MANUAL page 25 of 37 VACUETTE one step ahead Temperature correction table for 2 row values C lt gt greiner bio one Reference Temp Temp Temp Temp Temp Temp Temp Temp Values 216 3 16 4 18 7 18 8 21 2 21 3 23 7 23 8 26 2 26 3 28 7 28 8 31 2 gt 31 3 24 27 24 23 21 19 17 15 15 93 103 96 91 86 81 75 70 70 9 TROUBLESHOOTING GUIDE Before calling for a service technician please check the handling of sample collection mixing procedures and operating instructions ALARM CAUSE REMEDY A A EAN lev a sample level high or low a repeat sample collection b the label was not placed in its b replace label and repeat analysis proper position Refer to page 23 Thermometer error Temperature error data analysis is not converted sensor malfunction to 18 C Call service assistance Data result is not printed verify in set up menu 6 if a Check power supply printer lI is enabled b Check cable c Replace printer Data result is not credible sample clot sample has foam sample measured after 4 hours from sample collection 8 repeat sample collection b re mix gently d have the instructions
5. Every attempt to use the SRS 20 Il ESR analyzer with a purpose different from the intended use must be considered improper 2 POTENTIAL DANGERS AND SAFETY PRECAUTIONS 2 1 User Precautions Before beginning the use of the analyzer the operator must know the rules for handling potentially infectious materials and for handling Electro mechanical systems 2 1 1 User Identification This ESR analyzer is intended for professional use only The operator must be trained for working in laboratory using hazardous materials and professional equipment The use of this ESR analyzer by a not trained operator is considered an improper use 2 2 Electrical equipment As all electrical equipment the power supply is a potential source of danger Please avoid handling electrical parts before disconnecting them from the power supply Never carry out maintenance on the instrument when it is under electrical tension Until the instrument is packaged as supplied the operator is protected against electric shock Pay attention to the following electrical parts the power supply and the printer The SRS 100 II analyzer is powered by low voltage and it doesn t present the same dangers of the equipment s powered by an electrical line Even though it has a voltage elevator circuit inside and it could provoke strong electrical shocks it is not dangerous for the service assistance personnel We suggest to disconnect the power supply every time a technical operator make
6. c one step ahead 4 7 Performance criteria and limitations 1 PERFORMANCE CRITERIA A Mechanical Optical precision of detection 0 2 mm B Variability Coefficient of analysis C V lt 5 sample depending C Automatic temperature conversion to 18C Manley table Accepted range 15 32 C D Acceptable range for blood drawing 10 4mm from normal E Max 10 Measuring points Intervals of 3 minutes F Measuring range 1 140 mm h G Memory capacity Up to 500 results H Patient identification limitation Upto 12 digits 2 LIMITATIONS A Strongly lipemic or hemolytic samples may alter reading capability B Sed rate values gt 140 mm h will be indicated with this mark only C Temperatures outside the given range will be accepted as 15 min and 32 max SRS 20 11 USER MANUAL page 13 of 37 VACUETTE uc c one step ahead 4 8 Functional Diagram SRS 20711 page 14 of 37 VACUETTE nucum one step ahead gt 5 SOFTWARE 5 1 ID Function 1 MEC m6 mih meh mt ref SRSZHA II To identify the samples use function ID which has 2 opuons 12345 678928 o0000 ooo moooo 00000 12945 ID1 Identification or insertion of sample ZR ee X gi insert id The instrument requests insertion of sample identification pm code either using the keyboard or by using a barcode m reader Cesc to EXLt The instrument then waits for the insertion of the sample in whatever positi
7. OUTPUT DTR Data Terminal Ready 5 GND Ground 6 EM m Do not connect 7 Do not connect 8 NPUT CTS Clear to send 9 EM ES Do not connect PINOUT OF THE BARCODE CONNECTOR WARNING Connect only original scanners Commercial scanner with RS232 connection may damage the instrument IN ION NAME DESCR PTION SRS 20 11 OUTPUT Do not Do not TTL Ser Do not Do not Ground Do not Do not Scanner connect connect ial data input connect connect connect connect power supply USER MANUAL page 37 of 37
8. This menu includes many possible configurations Feilen RM Mus which can be modified by the user Normally PRIMER no Mara matum j j j j j HOST H WES AUTO configuration takes place during installation of the Hast r E YES tee instrument and does not require modification TIME E 12 45 The configuration menu can be activated only if the instrument finds itself in the stand by mode when there are no samples under analysis Note the variation of some parameters of configuration requires a further re setting of the instrument The instrument identifies these cases and re starts automatically The configuration of the instrument can be varied simply by using the key cursors The cursor by emphasizing the symbol gt white on black background identifies the configuration that can be modified with key cursors left and right or in case of date and time with ENT key followed by the desired value The parameters of possible configuration are RESULT 30 1h and 2h The operator can choose the kind of result If result 30 is selected YES the analysis results correlated to Westergren method are obtained in 30 minutes If results 1h is selected the analysis results are obtained in 30 minutes but the instrument shows also the 1 h result If results 2h is selected the analysis results are obtained in 1 h but the instrument shows also the 2 h result TEMP REF if this function is selected YES the r
9. USER MANUAL page 29 of 37 VACUETTE sie eats oS one step ahead 11 PACKAGING INFORMATION BOX SIZE 43 x 60 x 30 cm WEIGHT 9kg instrument protection dust cover user manual power supply GREINER CONTROL UNIT SERIEN MULA US j power cable thermal printer paper self test tool SRS 20 11 USER MANUAL page 30 of 37 VACUETTE um Uc one step ahead gt APPENDIX A THEORETICAL INFORMATION A 1 Westergren Method This is the standard method in accordance with the National Committee for Clinical Laboratory Standards It consists in a support that keeps the Westergren tubes containing non clottable blood perfectly vertical and hermetically sealed Westergren tubes have a diameter of not less than 2 55 mm and are graduated up to 200 mm As soon as the sample is taken it is mixed with a 3 2 sodium citrate solution in the ratio of respectively four to one 1 6 ml 0 4 ml of sodium citrate The blood thus prepared and well mixed is drawn into a Westergren tube up to the zero mark The tube is putted in the appropriate support and the erythrocyte level is read after 60 and 120 min A 2 Variations of ESR A Net increase of ESR 100 mm or more per hour 1 Multiple myeloma and 12 Internal hemorrhage Waldenstrom macroglobulinemia 13 Acute hepatitis 2 Malignant lymphoma 14 Ectopic pregnancy 3 Leukemia unbroken after the third month 4 Serious anemia 15 Broken ectopic pregnancy 5 Carcinoma
10. for sample mixing been used e Did you consider the automatic temp conversion of the SRS 20 11 CCD Scanner does not read barcode a Check cable b Re configure scanner See manual c Call service assistance HOST communication failure a cable a Check cable if it is correct b SRS 20 II is in main menu C There is no data in memory d call service assistance Info on display is readable but Neon lamp display broken call service assistance background is dark Memory error Memory broken call service assistance Keyboard is malfunctioning S call service assistance Clock error lithium battery flat or clock IC call service assistance broken SRS 20 II page 26 of 37 USER MANUAL VACUETTE y uo vc one step ahead NOTE For validations of test results please refer to CLSI document H02 A5 Vol 31 No 11 Procedure for the Erythrocyte Sedimentation Rate Test Fifth edition Approved Standard National Committee for Clinical Laboratory Standards SRS 20 11 USER MANUAL page 27 of 37 VACUETTE vc one step ahead lt gt greiner bio one 10 TECHNICAL SPECIFICATION SRS 20 II Area of application Instrument size Weight Voltage Operating Conditions Analysis time Analytical capacity Reading chamber Loading capacity Loading pattern Results Temperature correction Measuring method Reading resolution Results resolution Blood drawing level acceptance fr
11. instrument maintenance 2 3 Mechanical equipment For the mechanical part of the analyzer we suggest to not open the machine before having disconnected it from the power supply If the power is on it is not dangerous for the operator but instrument would damage if brought into contact with the parts in movement 2 4 Biohazardous material As with all in vitro diagnostic equipment patient samples and quality control QC products that are assayed on this system should be treated as potentially bio hazardous All materials should be handled according to your facility s biohazard procedure Always wear the personal protective equipment recommended by your facility when using the analyzer SRS 20 11 USER MANUAL page 5 of 37 VACUETTE uum Uc one step ahead gt 2 4 1 Human samples Always wear gloves and eye protective glasses when handling human samples Treat all samples as potentially bio hazardous and infectious If any sample is spilt on the instrument utilize the correct personal protective equipment PPE gloves lab coat etc wipe it up immediately and clean the contaminated surface with a disinfectant e g sodium hypochlorite 0 596 solution 2 4 2 Waste solution and solid waste Avoid direct contact with waste solution and or solid waste Both should be handled as potentially bio hazardous Dispose of waste solution and or solid waste according to local governmental regulations 2 5 Notes on safety measure Please pa
12. lt gt greiner bio one Software Version V 1 2 Contents Description of the host connector pinout and output data format HOST CONNECTOR SIGNALS DESCRIPTION Instrument 9 pin male connector PIN DIRECTION NAME DESCRIPTION 1 an ie Do not connect 2 INPUT RXD Serial data input 3 OUTPU TXD Serial data output 4 OUTPU DTR Data Terminal Ready 5 mim GND Ground 6 i E mE Do not connect 7 gt lt Do not connect 8 INPUT CTS Clear to send 9 E m Do not connect NOTE for system using only 3 wires To force a 3 wires connection TXD RXD e GND it is possible to connect on the device pin 4 to pin 8 EXAMPLE OF A CONNECTION TO A PC IBM COMPATIBLE COMPUTER ote Connectors are 9 pin female 2 gt gt 3 e 2257 e rem 2 4 8 8 4 5 252 5 HOST CONNECTOR SIGNALS DESCRIPTION 1 Data format is 9600 bps 8 data bit 1 stop bit no parity or no protocol 2 In order to make this document clear the character tilde hardware protocol RTS CTS is used in place of a space when there is more of one space and spaces are important for data collection 3 Control characters sent by the instrument is STX code 2 decimal in this document replaced by the string STX ETX code 3 decimal in this document replaced by the string ETX HOST DATA TRANS
13. whose values can be shown as w 0 sample under analysis LEV if error level REM if sample error lt mmm mmm result in millimeters on the right gt 140 result more than 140 millimeters 30mm 1h analysis result whose values can be shown as w 0 sample under analysis Wee if the result of mmmm is an error or the value is higher than gt 140 lt mmm mmm result in millimeters on the right 2140 result more than 140 millimeters 60mm 2h the result of the analysis can have the following values w 0 sample under analysis a if the result of mmmm is an error or the value is higher than gt 140 mmm mmm result in millimeters on the right gt 140 result more than 140 millimeters Note the 60mm result is present only if the instrument works in mode 60 eee is send if the instrument works in mode 30 SRS 20 11 USER MANUAL page 35 of 37 VACUETTE uum c one step ahead iw ESCRIPTION OF THE DATA FRAME Any string of characters is transmitted with the following frame lt STX gt string lt ETX gt ECC ECC represent th checksum used to detect if a string transmitted is defective Th checksum is encoded as two characters sent after the lt ETX gt character The checksum is computed by adding the binary values of the characters in a string modulo 256 and keeping the least significant 8 bits of the result The 8 bits can be consi
14. Born o activate control reading via their identification to t oooo0 8 onnon BEER view and modify theoretical control values to view and E a 9 B ac prt print the control graph and possible to cancel data if GC DEL the operator has made a mistake It is not possible to alter control values measured by the instrument If necessary the controls memory may be cancelled There are two memories for control management one for normal controls one for pathological controls The capacity of both memories is 30 values corresponding to 30 days a month if the control is viewed daily IMPORTANT For the correct use of the control material lease read carefully the instructions contained in the hematological control kit QC ID Identification and insertion of control samples ETE Tr To MEGAS As for the normal function ID this function allows the insertion of the codes for the identification of the insert id control samples you want to analyze The instrument will accept only previously inserted codes with the function ID INP SRS 20 11 USER MANUAL page 16 of 37 VACUETTE one step ahead Insertion of the code is then required and then sample insertion is expected The instrument identifies the position automatically and shows on the left part of the display control samples co ordinates and code The ESC key allows to interrupt the inserting procedure The so identified samples will be analyzed as the nor
15. CRITERIA AND LIMITATIONS eene n e n nen nene nnne nnn nnn nnn n nenne sese nono nono nn nono nononononononannns 13 4 8 FUNCTIONAL DIAGRAM a ei 14 S SOFTWARE A deese seesi o enee sa eeaeee i es eeue esio oe neito e esaesa eede es deese esio oo neiste eisa ee 15 ILID FUNCTION Da NC eee 15 2 2 MEM FUNCTION 2 eesosa eer eed aee ias 15 YI OC FUNCTION De esse a I I E IM A 16 54 PRINT FUNCTION 4 EUER 18 5 23 HOST FUNCTION Di ida 19 5 6 SETUP FUNCTION O eiii liada 19 3 7 PRINTER PAPER BRED aid 20 A O 21 6 1 SRS 20 11 CAN GIVE DIFFERENT KINDS OF RESULTS ccccccccncnnonononononononononononononononononononononononononononononononononenonenecenecinacesos 21 6 2 RESUETS CORRECTION TO I SC 2 are Goonsdbacoousceeccdndabeutentusdceede lee een een nennen 21 7 WARNINGS INFORMATION n 22 TL LEV LEVELERROR nd E seussaceawecubseguessades 22 7 2 REM SAMPLE REMOVED ERROR cccccecssssssscecececsensaecececccsessseaececececsenseaeeeceeecsensaaesecececseseaaeeeseceesesesaaaececeesesensnaeas 22 T SYSTEM ERROR WARNINGS ri 22 8 MAINTENANCE DR 22 8 1 CLEANING AND DECONTAMINATION INSTRUCTIONS cscsececeseeececeeseecececececececececececeeecececeeeceeeeeeeeeeeeeeeeeeeceeseeeeeeseeeeess 22 8 2 PAPER REPLACEMENT INSTRUCTIONS cccccececeeesecececececececececececececececceececececeeceseceseecececetecececececececececececeeeceeeceeevereeeeacs 24 8 3 PERIODIC TEST M
16. MISSION REQUEST FROM HOST COMPUTER The host computer could require data transmission by sending the character Data transmission starts only if the operator is not using the instrument Still executing any menu command no chars will be transmitted SRS 20 II USER MANUAL page 34 of 37 If the instrument VACUETTE uum c one step ahead gt MESSAGES SENT IN THE BEGINNING Instrument model 4MODEL xxxxxxxx V 1 2 Note The model name and version of the software can be different Device configuration MODE 30 T CORRECTION ON or MODE 60 T CORRECTION ON NOTE both values 30 and 60 depend on the analysis time mode respectively 30 or 60 The string T CORRECTION ON will be added only if the temperature correction is enabled Date and Time DATE GG MM AAAA HH MM Operating temperature TEMPERATURE gg rC where gg r is the operating temperature value with one decimal Transmitted only if the temperature correction is enabled MESSAGE ENT FOR ANY RESULT STORED IN MEMORY un sss ppp cccccccccccc mmmm 30mm 60mm where sss is the sequential sample number 001 999 ppp sample position example on 100 channel instrument from A01 to J10 on 20 channel instrument from 1 to 20 ccccccccccce patient ID Gode Meda e if not present left aligned mmmm 30 analysis result
17. On the display appears This indication appears every time the instrument is Gav 15 CHANGED switched on a new day This message indicates that by 4 1etina results pressing ENT key all data from the previous day will Sis EsP ES shore be deleted and memory will be cleared and positioned into position one By pressing ESC key all the results remain stored in the memory max 500 results CHECKUP Instrument will start the initialization wait please At the end of initialization appears this message self test DK SRS 20 11 USER MANUAL page 8 of 37 VACUETTE nucum one step ahead Main menu On the screen the main menu appears In the first line CFG it is indicated BEER n 28 wih och mt ref SRSZBA II which configuration is present at that S12145 ces B moment The black mark preceding 30 1h or 2h indicates which kind of result will appear at the end of analysis t ref if is active indicates that results will be corrected to the 18 reference temperature The configuration can be changed using the function 6 SETUP In the lower part of the screen it is possible to see the ID of the sample is in analysis Simply move the cursor on the screen over the position of the sample using the arrow keys Functions are numbered from 1 to 6 To fully understand each function please refer to the Software chapter 3 3 Instrument set up Once that the instrument is instal
18. aesesececsessuasseseeeceeseanaetes 5 2 4 BIOHAZARDOUS MATERIAL sense ea l 5 2 4 1 Human samples iia EP pee eus te uere e truc ti 6 2 4 2 Waste solution and solid Waste ooocccccocononocanicononanananononccnnonanonononococonononononoccnnannnnn nono nnonannnnnnnnccccnnnns 6 2 5 NOTES ON SABETY MEASURE 5 e RR ERI IEEE EGER E UE EDEN LEUR NER ERE bene SURE Ses epe ERE HEU EE nennen 6 2 6 DISPOSAL AND REC Gili 6 2 7 BIO HAZABRDOUS PARTS DISPO acia 6 2 8 ADDITIONAL PRECAUTIONS ee CER ENTRE ES 7 3 INSTALLATION 82 ee 8 3 1 POSITIONING OF THE ANALYZER cccccccecececececsescececeeseseessescecseececseeeseesececececeeseeeececececeeseecececseececececececeeeeseseecececseeeecececs 8 3 2 POWER ON P RO K 8 BS INSTRUMENT SET UP ep eeee erbe eese d 9 3 4 INSTRUMENT STAND BY 5 eete tees c hb uc ea ee bei cose bd sceau tea bene tii te cubes 9 4 SYSTEM DESCRIPTION ccccissiicesscccccesoosessescdsevesstestsoascscesestesesonccedesonscestbeasessasdactesedsosdedsveusdesdesasabaccostesadsosesdevess eces 10 2 LSAMPEE COLLECTING 2 da te tes teens da each ALD cp tue de nec D eL T eue 10 4 2 LABELING da 10 4 3 TEST TUBES ANN sini 44 52 ada 11 42 SAMPEEMIXING eerte pede cete pe ae ee creto edet erregen crede exe ne dE 11 IA MEN SER Ni cola 12 4 6 S YMBOLSIDENTIFICATION acid 12 4 7 PERFORMANCE
19. age 10 of 37 VACUETTE nucum vc one step ahead 4 3 Test Tubes handling Handling requirements The vacuum test tube needs to be inserted properly into its holder to obtain the automatic draw of 1 5 ml or 1 6 ml of blood required by the analysis Tubes are removed from the holder only after the draw has been completely terminated i e the required amount of blood for the analysis has been properly evacuated In case of an incorrect blood collection the SRS 20 II will refuse to analyze the sample indicating lev Level Error because the Sedimentation Rate result would be incorrect due to an erroneous ratio with the anticoagulant present in the tube All vacuum test tubes need to be mixed gently immediately after the blood collection to ensure the proper mixing of the sodium citrate with the freshly drawn blood Therefore tubes are gently turned inverted five times ensuring that the air bubble floats from one end of the tube to the other It is essential that before ESR determination is started the sample tube is carefully re mixed ten times according to the procedure as described above Storage requirements Store the test tubes at room temperature always below 30 C Never place the bench top tube container 50 tubes near a heating device or close to a window where direct sunlight could create unwanted heating effects 4 4 Sample mixing If it is not possible to analyze the sample immediately after sample collec
20. age 24 of 37 VACUETTE m 8 3 Periodic test In order to assure the correct performance of instrument and obtaining precise results it needs to perform a periodic test once a month which checks the accurate calibration of device The test has to be done using the Greiner Control Unit Control Tools This tool can be used by service people to check the mechanical calibration and functionality of the instrument It can be used to check Mechanical calibration of the reading system Mechanical level reading reproducibility Tubes reference levels reading at ambient temperature Results conversion at the reference temperature of 18 Internal temperature sensor readings HOW TO ENTER INTO SELF TEST FUNCTION Enter SETUP menu function and then press 002 The reading plate starts to move up and down Insert the Control Tool tubes with 60 50 and 30 mm reference level respectively in positions 1 2 and 3 of the instrument reading plate After a while the reading plate must complete a reading cycle down up on the display the following information will appear this is just a screen example TEST Temperature lt internal instrument temperature Calibration lt mechanical calibration reference must be 300 10 Delta lt mec delta between reading cycles must be within 2 1 lt 1 row values 1 2 row values The 1 results row values mustbe 1 24 4 5 93
21. d it must be gently mixed by inverting it at least five times If SRS 20 II is installed in the surgery the sample can be immediately analyzed by placing it in the first free channel Anyway the sample must be analyzed within three hours after blood collecting paying attention to external agents shown below that might alter ESR in the pre analysis phase External agents a Dilution ratio Bubbles Strongly hemolytic samples Sudden agitation Temperature Time after blood draw Direct sunlight Foam Lipemic samples 4 2 Labeling Identify the sample writing the patient identification code on the original test tube label or applying a barcode label Follow the scheme in Fig 1 to carry out this action correctly In the figure the test tube A has the correct blood level and original label on which write the patient code or other data if the bar code is absent The part H shows the zone that must be absolutely free to allow the infrared rays to recognize the right blood volume The test tube B shows code bar label correct position Test tubes C and D illustrate how erroneous labels positioning obstruct reading of the tube LABEL LABEL U YES YES NO NO SRS 20 11 USER MANUAL p
22. d only the results and data concerning the sample identification DATE TIME Time is printed memorized and transmitted to the host With this function the operator can set the internal clock 5 7 Printer paper feed When the instrument show the main menu the printer paper can be advanced by pressing the CANC key on the keyboard Warning do not pull out the paper by hands If the printer paper need to be replaced please follow instructions explained at the end of this manual on Paper Replacement Instructions appendix SRS 20 11 USER MANUAL page 20 of 37 VACUETTE nucum c one step ahead 6 RESULTS 6 1 SRS 20 Il can give different kinds of results a results correlated to 1 hour Westergren mainly used in several countries b results correlated to 1 hour and 2 hours Westergren C results correlated to Y hour 1 hour and 2 hours Westergren The operator can select the kind of result using the SETUP function The working time for option a is 30 minutes while for option b and c is 60 minutes Each laboratory should validate and evaluate its own ESR reference values 6 2 Results correction to 18C The results achieved are correlated to the method of reference considering the room temperature SRS 20 Il measures constantly the inner temperature further reconverts the values in according to the Manley table 6 shown below at the temperature of 18 Therefore this instrument guarantees a better reproducibili
23. dered as two groups of 4 bits which are converted to ASCII and represented in hexadecimal format The two ASCII characters are transmitted as the checksum with the most significant character first Using the following frame as an example the checksum for this frame is calculated Example lt STX gt ABCDEFGHI lt ETX gt 70 Character ASCII value A 065 1 character for calculation B 066 one C 067 etc D 068 etc E 069 etc F 070 etc G 071 etc H 072 etc I 073 etc lt ETX gt 003 etc Total sum value 624 Module 256 624 is 112 Then 112 decimal is 70 hex ECC is 70 If ECC length is 1 character the resultant ECC is adding a zero character ASCII 48 on the left Example First ECC A The resultant ECC is OA PINOUT OF THE PRINTER CONNECTOR PIN DIRECTION NAME DESCRIPTION 1 PULS Do not connect 2 E S Do not connect 3 OUTPUT TXD Serial data output 4 OUTPUT DTR Data Terminal Ready 5 GND Ground 6 RE ES Do not connect 7 EE Tue Do not connect 8 INPUT CTS Clear to send 9 Do not connect SRS 20 11 USER MANUAL page 36 of 37 VACUETTE c one step ahead PINOUT OF THE HOST CONNECTOR lt gt greiner bio one PIN DIRECTION NAME DESCRIPTION 1 Do not connect 2 INPUT RXD Serial data input 3 OUTPUT TXD Serial data output 4
24. esults will be referred to the standard temperature of 18 to avoid the result falsification due to external temperature SRS 20 11 USER MANUAL page 19 of 37 VACUETTE uum c one step ahead PRINTER This function permits the operator to choose different printing see Appendix In the default setting is selected the internal printer I which is incorporated in the instrument Any other selection implies an external printer connected to the instrument GRAPH The option NO deactivates sedimentation curve visualization In this way the instrument will not analyze the intermediate level every 3 minutes and so the life of the mechanical and electronic parts subject to movement are prolonged The option YES permits management of the curve which can be viewed and printed by pushing the button ENT from the main menu The option AUTO activates the automatic printing of the sedimentation graph together with the printing of the results of the samples HOST If the option NO is chosen when the operator switch on the instrument it doesn t control the HOST system connection but the function HOST still remains available If the option YES is chosen the instrument makes the initial control of HOST system connection The system HOST must be connected and ready to receive the data The option AUTO means that as soon as analysis is finished data will be transmitted immediately to the host In any case will be transmitte
25. he lower part of the screen displays the values calculated by the instrument itself and relative to the results present in the controls memory SRS 20 11 USER MANUAL lt gt greiner bio one gC SAMPLE ID EEN insert sample 188246641 Cesc to exit GC CODE IN Lr B3 Ba 188627 246841 GC INPUT insert id esc to exit BE IMPUT GC CODE MENOS insert id CODE HOT VALID esc QC 1 103109027 to ex Lt QC 2 1635245654 BE IMPUT BE CODE 185188827 insert id HEU GC CONTROL DELETE OLD GC DATA CCANC TO CONFIRM Cesc QC 1 166166824 to esit QC 2 168246641 SRS1aG T1 QC IMPUT BE CODE 185188827 insert id HEW GC CONTROL DELETE OLD QC DATA CANC TO CONFIRM CENT TO COMFIRH esc QC 1 1050105024 to esit QC 2 168246641 THEORIC GC REF EDIT z 54 5 Ux Ac 1 Bc 2 16816862410 188246841 Lot Mean 46 so 4 Calculated SHFL H 26 MEAN d So 8 20 0 EEN QC EDIT Cent to edit USE arrows to Mowe Cesc to exit page 17 of 37 VACUETTE nucum one step ahead QC CH chart Visualization of the control chart Juden Plot This function displays the control chart relative to the 3 6362 62 QC values memorized in the memory which are visible 3 in the left part of the screen B 11 83 82 The cursor is highlighted by an inverted color bar and ca
26. ification and replacement of the sample 7 3 System Error Warnings CFG Se ih sch t ret SRS If some troubles are found during the instrument O12 45 ce5 B operation samples analysis is not compromised but a ID 5 n 12345 Eras symbol will be displayed in the center of the monitor as unmnn 5 20000 B nen mjoodo o0000 in the following picture In this case the instrument must 12345 erssm B ac PRINT B Host SETUP be checked by the service assistance in order to identify and eliminate any trouble If the problem is more serious for instance the instrument finds problems with the mechanical movement of the reading plate the following message will appear on the display ERROR System Stopped After this indication the instrument will stop to operate and the technical service must be called 8 MAINTENANCE The instrument does not require a maintenance under normal user conditions but a preventive maintenance can reduce a spontaneous instrument failure Please pay attention to the cleanliness of the upper part test tube positioning plate which must be covered when the instrument is not used Do not clean the upper plate with liquids or damp cloths The entry of liquids or solid material into the reading channels can cause considerable damage to the instrument Do not clean the upper plate with liquids or damp cloths The entry of liquids or solid material into the channels can cause considerable damage t
27. led the operator entering in function 6 when instrument is in stand by mode can decide the work method Following appears on the display Using the arrow key move the cursor to EREED 11 select the desired configuration il del SETUP RESULT 38 EM YES use Arrous This instrument has an internal printer E AN i m xcd therefore the default setting is already on temp pee El no ent Internal If the operator chooses an PRIHTER HO 1 2 3 change date external printer select 1 or 2 or 3 ae UON al and time i i esc regarding the type of printer DATE 11 12 2003 a TIME 12 45 To show graphics of sedimentation select YES If AUTO is selected the graphic will be printed automatically at the end of analysis 3 4 Instrument Stand by On stand by mode the instrument is ready to accept and analyze samples Before starting the operator should read carefully chapter 4 SOFTWARE of this manual SRS 20 11 USER MANUAL page 9 of 37 VACUETTE nucum c one step ahead gt 4 SYSTEM DESCRIPTION 4 1 Sample collecting Samples must be collected following the vacuum collection technique using VACUETTE ESR Test Tubes 1 6 ml draw Item Nr 729093 or 1 5 ml draw Item Nr 729073 During sample collecting to be sure to have the right volume of blood it is necessary to wait until the test vacuum tube finished the blood drawing The test tube contains 3 296 sodium citrate as anticoagulant and immediately after collecting bloo
28. mal samples and the final result will be available both in the results memory and in the controls memory QC INP Inserting theoretical data for controls This function enables insertion of theoretical data referring to controls used for testing the correct functioning of the instrument The identification code is required and it contains all the necessary information This code is included in the control box and can be easily inserted using a barcode reader connected to the instrument Alternatively the code can be inserted by the keyboard If the inserted code is not correct the instrument displays an error message If the inserted code is recognized by the instrument no further operation is required If the code is not known the instrument warns that it is a new code and awaits confirmation by the user in order to go on with cancellation of the memory relative to the type of control previously inserted The cancellation of memory is necessary to avoid juxtapositions of data of different controls The confirmation requires the pushing of 2 different keys CANC and then ENT QC EDIT Visualization and modification of control values This function allows to visualize and modify the theoretical values of the control samples By using the arrow keys left and right you can select the controls 1 or 2 and with the ENT key you can modify the values Mean and SD You can use the ESC key to return to the previous menu T
29. n be shifted using arrow keys The right part of the l Jose screen displays the control graph and the value which an SD LM is highlighted by a small square The values which fall 23 082 outside the area of the control chart are highlighted with small squares all completely black The rest of the graph includes a series of information calculated automatically by the instrument itself The information is Number of the control number of results in memory average standard deviation and coefficient of average variation The points on the graph represent the intersection between the values of normal control horizontal axis and the pathological one vertical axis The values are acceptable when the points fall in the area of the central square limit 2s When the values fall outside this area the system is out of control and has to be controlled QC DEL Cancellation of control memory EGER ERR This function allows the total cancellation of QC data gathered in the memory Please note the theoretical ent to accept a te ane values of the control samples will not be in any way E oc ED altered Only QC INP and QC EDIT functions can GC CH modify such values A confirmation of the cancellation B ac PRT of data using the ENT key is required QC DEL 5 4 PRINT Function 4 Printing of the results or work list W LIST With this function the instrument prints a detailed list aba ss uih eh mt vef of the
30. nce 11 333 4 International Committee for Standardization in Hematology 1977 Recommendation for measurement of erythrocyte sedimentation rate of human blood American Journal of Clinical Pathology 68 505 5 LASCARI A D 1972 The erythrocyte sedimentation rate Pediatric Clinics of North America 19 1113 6 MANLEY R W 1957 The effect of room temperature on erythrocyte sedimentation rate and its corrections Journal of Clinical Pathology 10 354 7 CLSI Document H02 A5 vol 31 N11 Procedure for the Erythrocyte Sedimentation Rate Test SRS 20 11 USER MANUAL page 32 of 37 VACUETTE nucum c one step ahead B PRINTER TYPES PROTOCOL DESCRIPTION The printer setup can be changed to 5 different modes NO Printer output is disabled Internal printer APS CP205MRS 1 for CUSTOM ENGENEERING DP24 and DPT282 printers custom protocol 2 ESC POS Graphic protocol type 1 3 ESC POS Graphic protocol type 2 The ESC POS type 1 protocol use the following control codes ESC 1 0 to set min line space 1 8 ESC 0 nn at to print graphic line ESC 1 32 to set normal line space 1 6 The ESC POS type 2 protocol use the following control codes ESC 0 0 to set min line space 1 8 ESC 0 nn at to print graphic line ESC 2 0 toset normal line space 1 6 SRS 20711 USER MANUAL page 33 of 37 VACUETTE Gone step ahead C HOST CONNECTION PROTOCOL Referred instruments SRS 100 II SRS 20 11
31. o the instrument 8 1 Cleaning and decontamination instructions Dust can be removed using an ordinary vacuum cleaner Pay particular attention to the test tube it must be well closed and the cap should not be never removed The label must be correctly positioned and well stuck to the test tube surface Label fragments could fall into the test channel and obstruct a correct infrared functioning during analysis SRS 20 11 USER MANUAL page 22 of 37 lt gt greiner bio one VACUETTE CA one step ahead 1 Wipe potentially contaminated areas of the SRS 100 II with a cloth or paper towel wet with 196 bleach solution Solution A Solution A about 196 200 ml hypochloride and 800 ml of reagent grade water Let solution set for at least 15 minutes Wipe Solution A from areas Wipe areas again with cloth or paper towel with reagent grade water to remove the Solution A 5 Dry areas thoroughly po Iw SRS 20 11 USER MANUAL page 23 of 37 VACUETTE uum c one step ahead 8 2 Paper replacement instructions 1 Press the green lever down as in picture below to lift the printing head 2 Cut the paper as in the picture 3 Lift the paper well centered 4 Align the paper and press the green lever back as in the picture NOTE If the paper is stuck into the printer please do the same as in point n 1 by pressing the green lever in order to remove the paper without making damage to the printer SRS 20 11 USER MANUAL p
32. om normal Display Keyboard Interface Printer interface CCD scanner interface Applicable standards General Directives SRS 20 11 Blood sedimentation rate analysis Width 360 mm Depth 455mm Height 190 mm about 5 5 kg external power 100 240 V AC 10 0 6 A 47 63 Hz output 5 V DC 0 3A 12V DC 1 2A temperature 15 32 C roo m temperature humidity 45 85 altitude up to 2 000 m overvoltage category Il pollution degree 2 for indoor use only sound level 24 dBA 30 or 60 as selected max 40 tests h 20 max 20 samples at a time random in Westergren mm by interpolation correlated to 1h or 1h or 2h automatic compensation referred to 18 Manley infrared barrier 0 2 mm 1mm 4 mm 10 mm Graphic LCD with back lighting 15 keys RS 232 bi directional RS232 serial output TTL serial input ISO 9001 2008 ISO 13485 2003 EN ISO 14971 EN ISO 18113 3 EN 13612 EMC Directive 2004 108 EC and LV Directive 2006 95 EC and following amendments 2002 95 EC 2003 108 EC USER MANUAL page 28 of 37 VACUETTE c one step ahead EMC Standards Safety Standards Machine Directives Transport and storage SRS 20 11 lt gt greiner bio one EN 61326 6 2006 IEG EN 61010 1 2001 IEC EN 61010 2 101 2002 IEC EN 61010 2 051 2003 98 79 EC 2006 42 EC Do not refrigerate during transport Storage temperature 4 30C Storage relative humidity 2096 8596
33. on The position will be immediately F i N i SAMPLE TO identified and the relative information appears on the left inserts part of the screen When you do not have any more Baoa samples to insert you can return to the previous menu with the ESC key The ESC key can be used also to terminate the waiting time of the sample insertion if beanie necessary ID2 Identification of the sample without insertion with work list Similar to the previous function with the difference being that the instrument does not wait for the sample insertion but gives automatically the co ordinate value of the inserted codes Please pay close attention when inserting samples in order to avoid identification mistakes 5 2 MEM Function 2 Results memory Management IS B CLEAR ENT to accept fl press ESC ta abortt a EDIT The MEM menu enables the operator to control results saved in the memory It is possible to erase the memory with the CLEAR function or to modify data with EDIT function CLEAR Erasing of results memory SRS1G TI This function allows for results to be erased completely and for the sequential numeration to be re set a dee CLEAR Confirmation is requested if the commend to delete data press ESC to abort Bl EDIT is given The ENT key must be pressed When data is erased this has no effect on the controls memory QC SRS 20 11 USER MANUAL page 15 of 37 VACUETTE nucum lone step ahead
34. s 16 Menstruation 6 Sarcomas 17 Normal pregnancy after the 7 Serious bacterial infections third month 8 Collagenosis 18 Oral contraceptives taken 9 Biliary or portal cirrhosis 19 Tuberculosis 10 Ulcerous colitis 20 Postcommissurotomy syndrome 11 Serious nephrosis 21 Dextran administered intravenously SRS 20 11 USER MANUAL page 31 of 37 VACUETTE nuo Uc one step ahead B Moderate increase of ESR C Normality of ESR most cases 1 Acute and chronic contagious diseases 1 First stage acute appendicitis 2 Acute localized infections in the first 24 hours 3 Reactivation of a chronic infection 2 Precocious integral ectopic pregnancy 4 Rheumatic illness 3 Malarial paroxysm 5 Rheumatoid arthritis 4 Cirrhosis of the liver 6 Myocardial infarction 5 Arthrosis 6 Mononucleosis 7 Acute allergies 7 Malignant tumor with necrosis 8 Virosis without complications 8 Hyperthyroidism 9 Peptic ulcer 9 Hypothyroidism 10 Typhoid fever 10 Lead or arsenic poisoning 11 Undulant fever 11 Nephrosis 12 Rheumatic carditis with cardiac decompensation 13 Whooping cough 1 THYGESEN J E 1942 The mechanism of blood sedimentation Acta Medica Scandinavica Suppl 134 2 WINTROBE M M and Landsberg J W 1935 A standardized technique for the blood sedimentation test American Journal of Medical Sciences 189 102 3 HARDWICKE J and SQUIRE J R 1965 The basis of the erythrocyte sedimentation rate Clinical Scie
35. s urban waste dv DC DIRECT CURRENT SRS 20 11 USER MANUAL page 7 of 37 VACUETTE Nm ene step ahead 3 INSTALLATION 3 1 Positioning of the analyzer The SRS 20 Il must not be placed near centrifuges oscillating agitators or other vibrating instruments that might cause movement of the bench Keep in mind that the ESR is very sensitive to vibrations that could cause a false increase of results The bench must be flat and level Direct light on the instrument and sudden changes of temperature should be avoided Keep a free area of at least 15 cm around the instrument to allow instrument cooling by the internal back panel fan Connect the instrument power supply only of the type described in this User s Manual Use the mains plug to disconnect the apparatus from the mains supply The mains plug must be accessible at all times 3 2 Power on Connect the power supply and all other devices according to the description of the instrument connections Insert the power supply plug in a socket with an earth connection Connect and switch on the SRS 20 ll using the switch situated at the rear of the instrument Each time the SRS 20 Il is switched on it carries out initialization of electronic parts and auto test mechanical checking The following information is printed out SRS 20 11 V X XX software version date time temperature ref to 18 C if temp correction is programmed temperature internal instrument temperature
36. samples actually under analysis The data 1 00558 09558 Y m relative to the co ordinates and the identification 8 D0000 Donna B i d i F 00000 00000 E E MEMORY codes will be printed E ooooo oooon E C o0000 00000 C HiBBHEE EBHBHR MEMORY 02345 678518 With this function the instrument prints all the results psx mer In contained in the memory The data comprises of sequential number identification code and the values relative to the memorized results SRS 20 11 USER MANUAL page 18 of 37 Vi CUETTE nucum c one step ahead 5 5 HOST Function 5 Transmission data to a host system This function starts the transmission of the data SAS2a 11 relative to the values contained in the results memory A confirmation to transmit through the ENT key is CENT TO Conrrmn B men required The transmission can be interrupted at any B oc time with the ESC key The protocol used for PRINT transmitting data is documented in the Appendix B Host Transmission can be requested directly by the host SETUP system through a button as described in the Appendix however transmission can only be started if the user is not carrying out operations on the main menu For this reason the instrument always returns to the main menu when the keyboard is not used for a certain period of time 5 6 SETUP Function 6 Software 1 H Configuration of the instrument RESULT 38 EM YES USE arrows RESULT ihr NO REN rd
37. tion it must be mixed delicately by inverting for at least five minutes before putting the sample into the instrument Use a rotating laboratory agitator or a dedicate agitator optional part VACUETTE MultiMixer Item Nr 836577 The recommended rpm value for mixing is 15 20 RPM If manually mixed the samples must be turned inverted at least 10 times ensuring that the air bubble floats from one end of the tube to the other SRS 20 11 USER MANUAL page 11 of 37 VACUETTE nucum one step ahead 4 5 Sample insertion After mixing the sample must be promptly transferred to the analyzer For this reason we suggest to place the mixer near the SRS 20 11 For practical use we suggest to insert the ID code immediately after removing the test tube from the agitator to avoid a consequent beginning of sedimentation Function ID 1 If the samples are in large number it is advisable to insert the PAT ID before function ID 2 and then place the samples in the instrument following the position indicated in the printed sample list The sample positions on the analytic plate are numbered on the horizontal rows from 1 to 5 and from 6 to 10 to indicate the position of each vertical row 4 6 Symbols identification Ol empty position El sample inserted without identification kn position with path ID awaiting sample E sample with identification fe end of analysis SRS 20 11 USER MANUAL page 12 of 37 VACUETTE nucum
38. ty instead of instruments which perform results without temperature compensation 6 Manley table correct analysis values temperature 18 C 15 C 18 C 20 C 25 C 30 C 5 4 5 5 6 8 10 9 10 10 12 16 20 18 20 21 25 31 30 27 30 31 37 45 40 36 40 42 49 58 50 46 50 52 60 71 60 55 60 62 71 82 70 63 70 72 82 93 80 72 80 82 93 104 90 81 90 93 103 114 100 90 100 103 114 125 SRS 20 Il converts the results to 18 degrees according to the table if room temperature is in the range 15 32 For lower or higher room temperatures the instrument converts temperature in this way 15 for lower temperatur es and 32 for higher temperature SRS 20 11 USER MANUAL page 21 of 37 VACUETTE nucum yy one step ahead 7 WARNINGS INFORMATION 7 1 lev level error When lev is printed the instrument has found an erroneous sample volume It means that the blood level is outside the range 4 or 10 mm from the theoretical value of 60 mm corresponding to a sample volume of 1 6 ml The message is given together with the sample co ordinates to allow an easy identification of the wrong sample Sample collection needs to be repeated 7 2 rem sample removed error When rem is printed the instrument has found abnormal behavior of the sample for instance extremely fast sedimentation or tube removing during the analytical phase The message is given together with the sample co ordinates to allow an easy ident
39. y attention to the sample collection The vacuum test tubes used for this instrument have been studied to draw the right level of blood To fill the test tube with a higher volume of blood could cause a serious infection risk for tube leakage Furthermore the leakage could damage the inner optical part of the instrument and annul the guarantee 2 6 Disposal And Recycling Herewith we declare that this instrument is subject to the European Directive 2002 96 EC RAEE Directive and 2003 108 EC Therefore the instrument must be disposed separately not as urban waste and delivered to the specific collection centre in accordance with the Directive 2002 96 EC and 2003 108 EC The user may request that the supplier collect the instrument for correct disposal if a new instrument is ordered 2 7 Bio Hazardous Parts Disposal All parts which have a direct contact with samples must be disposed as POTENTIALLY INFECTIOUS Follow local regulations SRS 20 11 USER MANUAL page 6 of 37 VACUETTE y um cc one step ahead 2 8 Additional Precautions The following symbols are placed on the instrument to assure correct usage N Attention read use instruction IVD For in vitro diagnostic use only ELECTROSTATIC DISCHARGE SENSITIVE DEVICE ESDS The device could be damaged by electrostatic potentials BIOHAZARD RISK Adopt protective measures to avoid any contamination gloves glasses etc DO NOT DISPOSE The instrument cannot be disposed a
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