Sed Rate Timer 10/II User Manual Downloads IFU - Greiner Bio-One
Contents
1. 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 SRT 10 ll 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 instrument maintenance 2 3 Mechanical equipment For the mechanical part of the analyzer we suggest to not open the m2. 12 Rheumatic carditis with cardiac decompensation 13 Whooping cough OONDOBW TO 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 Science 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 N41 Procedure f or the Erythrocyte Sedimentation Rate Test B PRINTER CONNECTOR Please turn off the instrument before connect any cable to the instrument PIN DIRECTION NAME DESCR ION 1 ms eem Do not connect 2 INPUT RXD Serial data input 3 OUTPUT TXD Serial data output 4 OUTPUT DTR Data Terminal Ready 5 GND Ground 6 aa ae Do not connect 7 OUTPUT 12 Power supply for external printer 8 INPUT CTS Clear to send 9 aa Do n
3. Printer cable b Check cable C Printer configuration c See manual for check printer configuration d Check printer test by power on when key f f is pressed printer Data result is not credible 8 sample clot 8 repeat sample collection b sample has foam b re mix gently C sample measured after 4 hours from sample collection d have the instructions for sample mixing been used e Did you consider the automatic temp conversion of the SRT 10 lII One or more a possible obstruction of infrared a Call service assistance on the display without tubes barrier by external materials label b Call service assistance being introduced parts etc b disconnection or defect of internal cable No info on display a power switched on a Switch power on b power supply working b Check power supply replace if c internal problem necessary c Call service assistance Info on display scrambled CS call service assistance Check the printer a Printer is connected but in OFF a Switch on the printer and on the display position re switch the SRT 10 lI b Set SW4 in ON position Call service a mechanical problems during a call the service analysis 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 SRT 10 11 USER S MANUAL Page 24 of
4. 0 11 simply placing test tubes in free position Otherwise samples should be analyzed within three hours paying attention to external agents shown below that might alter ESR values in the pre analysis phase A B C D L LABEL LABEL YES YES NO NO Figure 6 SRT 10 11 USER S MANUAL Page 16 of 29 VACUETTE o eae os one step ahead gt External agents Dilution ratio Bubbles Strongly hemolytic samples Sudden agitation Temperature Time after sample taking Direct sunlight Foam i Lipemic samples So sacs a 5 5 Sample mixing When it is not possible to analyze the sample immediately after sample collecting it must be gently mixed by inverting for at least five minutes The use of a rotating agitator VACUETTE MultiMixer Item Nr 836577 is recommended The suggested rpm value for the mixer is 15 20 RPM 5 6 Sample positioning After mixing the sample must be promptly transferred to the analyzer We suggest to place the mixer near the SRT 10 ll It is also recommended following a numerical sequence while channels loading After inserting the tenth sample wait for the results of first loaded samples remove the analyzed samples from their channels and put new test tubes in these channels to continue the analysis On th
5. 29 VACUETTE one step ahead gt lt gt greiner bio one 11 TECHNICAL SPECIFICATIONS Area of application Instrument size Weight Voltage Hz Operating Conditions Reading chambers Analysis time Analytical capacity Loading capacity Loading pattern Results Temperature correction Measuring method Reading resolution Results resolution Reading points Blood draw level acceptance from normal level Interface Applicable standards SRT 10 11 Blood sedimentation rate analysis Width 290 mm Depth 190 mm Height 170 mm about 2 kg external power 100 240 V AC 10 1 8 A 50 60 output 12 V DC 1 5A temperature 15 32 C ro om temperature humidity 4596 8596 altitude up to 2 000 m overvoltage category Il pollution degree 2 for indoor use only sound level 32 dBA 10 30 max 20 tests h max 10 samples at a time random 1 h mm Westergren by interpolation or h and 1h Westergren or 1 h and 2 h Westergren or with graphics on the printer automatic compensation referred to 180 C Manley infrared barrier 0 2 mm 1mm up to 20 4 mm 10 mm RS 232 C for printer 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 USER S MANUAL Page 25 of 29 VACUETTE v one step ahead gt General Directives EMC Standar
6. ENT RE conce 5 2 MECHANICAL EQUIPMENT RR RHET EEIT E 5 2 4 BIOHAZARDOUS MATERTAD visi 5 etes eee eene oven voee ue e ve E E Ee E EN E EE Va Rent va qus es veo eon eo vu o een ea ves eee a ua ve esses eoa vele os uve gs 5 24 Human samples RR e RAIN aeE Un 6 2 4 2 Waste solution and solid waste no cano nono n carne no cnnn nono ette nc estere esee tres ea tene sesta 6 2 DINOTES ON SAFETY MEASURE esca 6 2 6 DISPOSAL AND RECAEN GA cs 6 2 7 BIOZ HAZARDOUS PARES DISPO ia 6 2 8 ADDITIONAL PRECAUTIONS cae 7 3 INSTALLATION E sise 8 3 1 POSITIONING OF THE ANALYZER aia 8 3 2 CONFIGURATION acid 8 3 2 POWER ON cuna aa tii dia 9 4 SYSTEM DESCRIPTION PC 11 Al SV S hai a rara aa 11 4 2 PRE INDICATION OF THE RESULTS cccccccccccceccccsecesecesecescecseseseseseecucecscecuaecuaecucesuaecuaucuaesuaeauaeauauauaussaeauauauauauauananaea 11 ASIMILA titles 12 AA READING PLATE tada LL E ten putain bec iE 12 2 S POWER SUPPLY ee NEA LIEU AE LR oaren 12 ZO PRINTER ita tada 12 A TEST DUBES3 nat oa IU d Lee ML aie 12 4 8 PERFORMANCE CRITERIA AND LIMITATIONS ccccccccccncconononononononononononononononononononononononononononononononononononnnnnnnononenininnnnnns 13 5 OPERATING PROCEDURE ei icccscdsccesovsossedivecesastustioasescesbustesesecdesosacasdsonsssdecbucevesesevsossedsoessdssolssacssesesedeosandecesstesseess 14 Del READING PRINCIPE dic 14 5 2 FUNCTIONAL SEQUENCE OF ANALYSIS ccsesscscceceesess
7. VACUETTE mo one step ahead gt CE Sed Rate Timer 10 11 SRT10 II including Software G2M100BO Vers 1 0 ESR Analyzer optional thermal printer available USER S MANUAL MAN 003 Revision 6 Revision date November 30 2012 VACUETTE one step ahead gt lt gt greiner bio one 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 Timer 10 Il SRT 10 11 including Software G2M100BO Vers 1 0 Short cut name SRT 10 11 Automatic Sed Rate analyzer 10 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 SRT 10 11 USER S MANUAL Page 2 of 29 VACUETTE o aan os one step ahead gt CONTENTS 1 INTRODUCTION mp 5 E NIN TENDED OSB oes ene Le m m E Lm 5 2 POTENTIAL DANGERS AND SAFETY PRECAUTIONS e eeeee esee ee eerta tana se tete tn ases sees tees sn sess see eese en nenes 5 Del USER PRECAUTIONS ier eee ee NES UO GERI ease ux be Quse esa VE exe Ne SEMEN Ne EN DEPT NER EIN UEEERESS 5 BAT User Identificalion e ta PER epo E Desa bee ee et Eos e cesa 5 APA ELECTRICAL EQUIPM
8. able After collected the sample observing instructions given in chapter 6 Operating procedure the operator can put the sample into the first free position of the SRT 10 Il Before putting the sample in the operator must record on the appropriate form the patient name or the patient code the sequence number of the analysis and mostly the position number 1 10 in which the sample is putted in After few seconds the display in the same position of the loaded channel shows this symbol E meaning the analysis start If after two minutes this symbol remains unchanged it means that the sample has been accepted by the level control made by SRT 10 ll at the beginning of the analysis If the sample is not accepted the message LEV appears meaning that the sample has not been properly drawn and the blood level in the test tube is not within the limits permitted by the instrument 4 10 mm from the theoretical level For samples with blood levels in the range 4 and 10 mm the results will be automatically adjusted by the SRT 10 Il software Other test tubes may be putted in following the progressive position order up to 10 Half an hour later each insertion the result in mm h Westergren will appear on the display in the position corresponding to the respective test tube and remains until the sample is removed 60 seconds after the sample removing the result will disappear to the display Now other samples can be loaded in the
9. achine 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 SRT 10 11 USER S MANUAL Page 5 of 29 VACUETTE o m c 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 5 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 pay attention to the sample collection The vacuum test tubes used for this instrument have been studied to draw the right level
10. alysis STAND BY TUBE DETECTION INDEPENDENT PRE INDICATION READING OF RESULTS PROCESS E READING TIME CALCULATION TEMPERATURE DETECTION TEMPERATURE CORRECTION RESULTS GRAPH ENABLE OPTIONAL PRINTING GRAPH SRT 10 11 USER S MANUAL lt gt greiner bio one Page 15 of 29 VACUETTE Hcc one step ahead gt 5 3 Sample collecting Samples must be collected following the vacuum technique with VACUETTE ESR Vacuum 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 5 4 Labeling Identify the sample writing on the original test tube label or applying a barcode label Follow the scheme in Fig 6 to carry out this action correctly In the figure the test tube A has the correct blood level and the original label on which write patient code or other data if the barcode is absent The part H shows the zone that must be absolutely free and transparent to allow the infrared rays to recognize the right blood volume Test tube B shows label correct position Test tubes C and D illustrate how erroneous label positioning obstruct the reading of the analysis If the instrument is installed in the surgery samples can be immediately analyzed by SRT 1
11. bottom of the display you can find the value of the internal instrument temperature On the right of the display there the mechanical calibration reference must be 300 10 The 1 results row values mustbe 1 24 5 93 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 Temperature correction table for 2 row values C 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 SRT 10 11 USER S MANUAL Page 23 of 29 VACUETTE iene ore one step ahead gt 10 TROUBLESHOOTING GUIDE Before calling a service technician please check the handling of sample collection mixing procedures and operating instructions ALARM OR TROUBLE CAUSE REMEDY 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 15 rem sample has been removed repeat analysis Temp sensor error Temperature error data analysis is not converted sensor malfunction to 18 C Call service assistance Data result is not printed a Printer power a Check power supply b
12. ced by another so it is possible to analyze up to 20 tests h SRT 10 Il has been developed to simplify ESR analysis avoiding sample manipulation and operator s infection risk To carry out the analysis the operator puts the sample test tube into the instrument The result appears on the display in only 30 minutes This feature allows the instrument to be used directly on the ward in the blood sample collection department and in small laboratories In carrying out the analysis SRT 10 Il controls the room temperature and converts the result to the reference temperature of 18 In accordance with Manley table The results conversion is necessary to avoid substantial variations of values due to different room temperatures 4 2 Pre Indication of the results Only 9 minutes after putting the sample in before the end of analysis the SRT 10 II can show on the display messages indicating a prediction of the result Result pre indication after 9 minutes mm h Visualization 9 0 9 0 29 gt 29 These symbols appear on the display in the same position of the sample channel SRT 10 11 USER S MANUAL Page 11 of 29 VACUETTE j uo a CA one step ahead gt 4 3 Display A 40 character two line LCD display with backlight allows a continuous monitoring of the analysis and a visualization of the results On the display can be also shown a sample or a system error message Please note that the display can indicate more than
13. connected the following message appears check the printer if the temperature compensation is active the following message appears on the display 18 C temp of reference 27 5 internal temp SRT 10 11 USER S MANUAL Page 9 of 29 VACUETTE j Hu one step ahead gt Instrument starts the auto test for mechanical and electronic control self test Several seconds after the display will indicate self test OK Now the instrument is ready for the analysis On the display appears this message temp 27 5 C SRT 10 11 USER S MANUAL Page 10 of 29 VACUETTE P m one step ahead gt 4 SYSTEM DESCRIPTION 4 1 Analyzer unit The SRT 10 11 ESR analyzer is an automatic instrument controlled by a microprocessor and exclusively employed for analysis of the erythrocyte sedimentation rate It s total absence of commands its precision and its ability to obtain the result already corrected to a temperature of 18 according to Manley in only 30 minutes ma ke it the most innovative and versatile system for this kind of analysis It constantly and simultaneously scans 10 test tubes which are custom made for ESR with this system SRT 10 II follows the sedimentation of each sample independently to each other memorizing levels for the whole period of analysis The instrument can be used for random and continuous loading of samples to a capacity of 10 test tubes each time When a sample has been analyzed it can be repla
14. de water to remove the Solution A 5 Dry areas thoroughly peo m SRT 10 11 USER S MANUAL Page 22 of 29 VACUETTE d vc one step ahead gt 9 2 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 controls the accurate calibration of the device The test has to be done using the Greiner Control Unit Control Tool 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 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 All other reading positions must be empty Turn on the instrument and wait The instrument detects this special condition and starts the self test 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 greiner bio one SELF TEST Temp 25 0 C a t 1 24 93 18C 1 19 81 M STEPS 300 On the left at the
15. ds Safety Standards Machine Directives Transport and storage SRT 10 11 lt gt greiner bio one 2002 95 EC 2003 108 EC EN 61326 6 2006 IEC 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 4 308 Storage relative humidity 2096 8596 USER S MANUAL Page 26 of 29 VACUETTE CA one step ahead gt 12 PACKAGING INFORMATION BOX SIZE 30x60 x 36 cm WEIGHT 3 5 kg G greiner bio one open box ACCESSORIES dust cover user manual m power cable SRT 10 11 USER S MANUAL instrument protection power supply self test tool Page 27 of 29 VACUETTE j o a 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 erythr
16. e D Acceptable range for blood drawing E Max 10 Measuring points F Measuring range 2 LIMITATIONS lt gt greiner bio one 0 2 mm C V lt 5 sample depending Accepted range 15 32 C 10 4 mm from normal Intervals of 3 minutes 1 140 mm h 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 SRT 10 11 USER S MANUAL Page 13 of 29 VACUETTE ccm one step ahead gt 5 OPERATING PROCEDURE 5 1 Reading principle Ten infrared barriers cover vertically the ten test tubes with a cycle of about 60 The whole test tubes every 0 2 mm gap are analyzed As soon as the reading plate including 10 pairs of I R TX RX begins to rise the software recognizes any positions occupied by samples containing the right level of blood At the first rising when the instrument has ensured that the meniscus is clearly distinct the level of the sample collection just inserted is checked and the analysis begins The computer records the zero time for each sample and all the following readings until 30 minutes have elapsed During this phase the instrument also recognizes if the sample is being proper kept in its channel SRT 10 11 USER S MANUAL Page 14 of 29 VACUETTE one step ahead gt 5 2 Functional Sequence of An
17. e display the operator can also check the proper location of the right channel in which to put the new test tube The sample positioning on the analytic plate are numbered from 1 to 10 Numbering is meant progressively in groups of 10 samples so when the analysis of the sample in channel number one is completed the new sample put in channel one automatically becomes the sample number 11 and so on with the other samples For sample identification if printer is disconnected the operator can use a form in which write the patient name or code number before the tube is put into the analyzer 5 7 Sample removal During the reading SRT 10 ll shows on the display the operative state of the instrument and the updated situation of current and already concluded analysis Before the final result is shown on the display the operator is advised by two short acoustic signals When the analysis is finished the result will be automatically shown on the display and transmitted by the serial line to the printer when connected and switched on Data will remain memorized on the display until the operator having noted the values removes the corresponding test tube from the plate After removing the test tube the data on the display disappear in about one minute and in the corresponding channel the operator can put a new sample SRT 10 11 USER S MANUAL Page 17 of 29 VACUETTE j o o CA one step ahead gt 5 8 Brief working instructions 1 Set up
18. ence temp sensor error This message can appear if the internal thermometer has problems In this case analysis results are displayed without temperature compensation SRT 10 11 USER S MANUAL Page 21 of 29 VACUETTE Cm one step ahead gt 9 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 9 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 reading function during analysis 1 Wipe potentially contaminated areas of the SRT 10 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 gra
19. hour Westergren with temperature compensation connected to the thermal printer Item number 836582 switches are placed Default Setting N Switch Position OFF OFF ON ON OFF OFF ON ON 0 o0 Ci A 0r SRT 10 11 USER S MANUAL Page 8 of 29 VACUETTE Nac ore one step ahead gt 3 2 Power on The cable that connects the instrument to the electrical circuit is the most important system of disconnection from the electrical source For this reason the cable must be easily reached and accessible by the user Connect power supply outlet to the instrument Insert the power supply plug in a socket with an earth connection If the instrument has an optional printer it should be connected to the SRT 10 Il with the appropriate cable and plugged in Connect and switch on first the printer then the SRT 10 Il using the switch situated at the rear of the instrument Each time SRT 10 II is switched on it carries out an electronic initialization a cancellation of the memory and an instrument check test On the display appears this message greiner Bio One SRT10 11 U 1 0 then configuration data appears 30 60 working time results 30 1h Zh mm If the printer has been connected this message will be also printed followed by the header of the results given at the end of each analysis If the printer is connected on the display appears this message print curve UM printer OK If the printer is off or not
20. instrument Connect power supply and printer 2 Switch on printer and analyzer unit On the display appears some information i e software release and this symbol appears for each free channel It indicates free positions on which the operator can put samples 3 Sample identification a Prepare E S R data report form b Write name or patient N on the tube and on the form following the channel position 4 After gently mixing for about 5 min put the tubes into reading channel following the form data 5 After 30 60 minutes the operator can read or print the results a If printer is connected there will be an automatic printout b If printer is disconnected the operator must read and record on the form values indicated on the display 6 After having the results remove tubes This symbol will appear indicating that this channel position is free for a new test tube Follow points 3 6 SRT 10 11 USER S MANUAL Page 18 of 29 VACUETTE o eae i one step ahead gt 6 TEMPERATURE COMPENSATION 6 1 Results correction to 18C The results achieved are correlated to the method of reference considering the room temperature SRT 10 ll measures constantly the inner temperature further reconverts the values in according to the Manley table 1 shown below at the temperature of 18 degrees Therefore this instrument guarantees a better reproducibility instead of instruments which perform results withou
21. ncononnnnonnnnnnononnnnonononcnnononnnnonnncnconannn canoso 23 10 TROUBLESHOOTING GUIDE sessssssssssccoccsosssesiscssscseccsceusboossevteessesscessdastecesatesdsesbecdssesetessoosscedeeeuscesusossceseeessdesdecss 24 11 TECHNICAL SPECIFICATIONS sisisssscssissonscosssssssosessassssscssecssscsoesvssssessbesssestosssesssssissonscodseceisedscsodsvaesosecsessoseesss 25 12 PACKAGING INFORMA TION scisesssssescccississscsssccsssesssccessssecsscessaecacscsecsadeescscantestesacseedssdsceseesssssvseuccsdseesessnasesseeasses 27 A AAA AT 28 A THEORETICAL INFORMATION 0 oc ccccccccccccccsessssssececececceeseseseeececeesesaseeececsenesaesecececeesesasaaeceeeeecsensaeeeeeceseneaaees 28 A 1 Westergren Method usa ia ie tee oerte ara dae ae a ecards 28 A 2 Variations OF ESA iia ie 28 ByPRINTER CONNEC TOR oia 29 SRT 10 11 USER S MANUAL Page 4 of 29 VACUETTE P m _ one step ahead gt 1 INTRODUCTION 1 1 Intended use The SRT 10 Il analyzer is an automatic instrument controlled by a microprocessor and exclusively employed for analysis of the in vitro diagnostics determination IVD of erythrocyte sedimentation rate ESR It constantly and simultaneously scans 10 test tubes which are custom made for ESR analysis The SRT 10 Il follows the sedimentation of each sample independently memorizing levels for the whole period of analysis Every attempt to use the SRT 10 Il ESR analyzer with a purpose different from the intended use must be considered improper
22. ocyte 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 Carcinomas 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 SRT 10 11 USER S MANUAL Page 28 of 29 VACUETTE CA one step ahead gt B Moderate increase of ESR Acute and chronic contagious diseases Acute localized infections Reactivation of a chronic infection Rheumatic illness Rheumatoid arthritis Myocardial infarction OahWNM 7 Malignant tumor with necrosis 8 Hyperthyroidism 9 Hypothyroidism 10 Lead or arsenic poisoning 11 Nephrosis lt gt greiner bio one C Normality of ESR most cases 1 First stage acute appendicitis in the first 24 hours Precocious integral ectopic pregnancy Malarial paroxysm Cirrhosis of the liver Arthrosis Mononucleosis Acute allergies Viruses without complications Peptic ulcer 10 Typhoid fever 11 Undulant fever
23. 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 SRT 10 11 USER S MANUAL Page 6 of 29 VACUETTE j o o CA one step ahead gt 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 as urban waste mn DC DIRECT CURRENT SRT 10 11 USER S MANUAL Page 7 of 29 VACUETTE pM c one step ahead g
24. one results for each sample according to dip switch configuration set up by operator To know which kind of analysis results are referred to please look in the bottom left position on the display where the message 30 1h or 2h will flash On the display the operator can also see the symbols shown below These symbols suggest for each sample the analysis time remaining EER time remaining symbols 4 4 Reading Plate One row of 10 test tube channels numbered from 1 to 10 4 5 Power Supply The low voltage supply built in accordance with international safety standards offers a valid solution to improving assistance service 4 6 Printer The printer is hooked up to the instrument with RS232 C outlet Whenever an analysis is completed it prints out the ESR results following the loading sequence The printer is external so it can be easily replaced when necessary lt can also be replaced by other printers with serial entry 4 7 Test Tubes The test tubes for this instrument are VACUETTE vacuum tube specially made for the SRT 10 Il instrument These tubes contain 3 2 sodium citrate and a vacuum which allows a 1 5 ml or 1 6 ml blood drawing SRT 10 11 USER S MANUAL Page 12 of 29 VACUETTE one step ahead gt 4 8 Performance criteria and limitations 1 PERFORMANCE CRITERIA A Mechanical Optical precision of detection B Variability Coefficient of analysis C Automatic temperature conversion to 18 Manley tabl
25. ot connect SRT 10 11 USER S MANUAL Page 29 of 29
26. ssesecececeenseaesececessessuaesecececeeseaaeseseceesesssnaaeeeesceesesseaeeeeeeeceeseaaees 15 5 3 SAMPLE COLLECTING 16 JA TGABED ING AAA ereere A AE a ETE tha e Eee OE 16 iR SAMP E MG iaa 17 5 60 SAMPLE POSITIONING a N 17 J I SAMP E REMOVAL its 17 5 8 BRIEF WORKING INSTRUCTIONS ais 18 6 TEMPERATURE COMPENSATION seesesesssossoesesesoseoeceessosooeoesesesooooesesssosoosoeessosooeoeeesescosoeeseesoseososessesoosoesssesoseoese 19 6 1 RESULTS CORRECTION TO I8 Caridad 19 AUREA a 19 T PRACTICAL No 20 7 1 HOW TO USE THE INSTRUMENT 5 pi cierto oa oto roo vo ient iia oe peo S esee ide 20 7 2 LIMIT OF THE INSTRUMENT di 21 8 ERROR INFORMATION AND WARNINGS scccsssscccsssscccssscccsssscccssscccsesssccccssseccsessneccscssseecsssacccessssececssceccess 21 8 1 WARNINGS INFORMATION oo2cccccscccsccccssceceessscacesesscececseacaceddavssceaee ensceeevessuaed vaeydades suvsasceceassacubeuaedsaauydgSvsouseedesseyeuerss 21 8 2 SYSTEM ERROR WARNINGS a n atlas 21 NS E E E A E EE E E A E A E E 22 9 1 CLEANING AND DECONTAMINATION INSTRUCTIONS sccsecesesececececeeccecececececeeecececececccececeeececeeeeececeeeseceseeeceeeeeeeeess 22 9 2 PERIODIC TEST ee 23 SRT 10 11 USER S MANUAL Page 3 of 29 VACUETTE a l greiner bio one CA one step ahead gt HOW TO ENTER INTO SELF TEST FUNCTION cooooooccncncnonnconanoncnnononnnnonono
27. t 3 INSTALLATION 3 1 Positioning of the analyzer The SRT 10 11 must not be placed near centrifuges oscillating agitators or other vibrating instruments that might cause movement of the bench Please keep in mind that 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 Users Manual Use the mains plug to disconnect the apparatus from the mains supply The mains plug must be accessible at all times 3 2 Configuration Before switching on the analyzer please set up the dip switch placed in the rear panel following the table below SWITCHES CONFIGURATION 1 enable 30 result 2 enable 1h and 2h result ON z 1h and 2h OFF z 1h 3 enable temperature compensation 4 enable the printer 5 enable sedimentation curve graph 6 not used 7 enable the internal fan 8 enable power supply on thermal printer connector 836582 DPT100 printer WARNING Do not switch on power when using a different type of printer as serious damage could be caused To enable each function be sure that the corresponding switch is placed in ON position For example to configure instrument for results corresponding to 1
28. t temperature compensation 1 Manley table correct values analysis temperatures 18 degrees C 15 degrees C 18 degrees C 20 degrees C 25 degrees C 30 degrees 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 SRT 10 Il converts the results to 18 degrees according to the table if room temperature is in the range 15 32 degrees C For lower or higher room temperatures the instrument convert temperature in this way 15 degrees C for lower and 32 degrees C for higher temperature 6 2 Result Each laboratory should validate and evaluate its ESR reference values SRT 10 11 USER S MANUAL Page 19 of 29 VACUETTE o aan one step ahead gt 7 PRACTICAL USE 7 1 How to Use the Instrument SRT 10 ll is very simple to use and the procedure can be learnt quickly Being already pre set no configuration is necessary after switching on so the operator does not input data For this reason there is no user interface keyboard The standard conditions which can be modified are the following a analysis time 30 minutes with report related in mm to 1 h Westergren refer to page 6 for different configurations b automatic adjustment of temperature with report related to the reference temperature of 18 in accordance with Manley t
29. vacated positions If the printer is connected to SRT 10 11 it will print out the results at the end of each analysis as follows Snpl Chan PatIDit 0 time minutes 60 104 14 iii j 30 1h zh 5 13 124 mn Smpl sample sequential number 1 999 Chan z Channel number 1 10 Pat ID fixed value at If the graphic printout has been activated you can see the de diagram here below in addition to the results SRT 10 11 USER S MANUAL Page 20 of 29 VACUETTE j Pc o A one step ahead gt 7 2 Limit of the Instrument SRT 10 11 reading limits is max 140 mm at 18 When a sample has a value gt 140 mm this message is displayed or printed gt 140 8 ERROR INFORMATION AND WARNINGS 8 1 Warnings information check the printert This message appears when printer is enabled in the SRT 10 11 but not switched on Meaning of symbol on display xxx Result xxx Awaiting sample gt xxx Sample value higher than xxx lev Error initial level error rem Error removed sample 8 2 System Error Warnings ERROR system stopped This warning will be given if the instrument finds problems with the mechanical movement of the reading plate during the initial self test Call service After this indication the instrument will stop and it need to call the technical service ERROR call service This message can appear if there is a mechanical problem during analysis 16 C temp of refer
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