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USER'S MANUAL - Frank's Hospital Workshop

1. Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 11 6 Forms The form in the next page regards the Training Course satisfaction you are kindly requested to fill this anonymous questionnaire and to return it to the following address EDIF INSTRUMENTS S r l Via Ardeatina 132 00179 Rome Italy Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 TRAINING COURSE EVALUATION FORM l ACTIVITIES EVALUATION Importance Specific Performance Satisfaction Mark 1 2 3 Instrument Overview 10 8 6 4 2 1 j 3 OS Software overview 10 8 6 4 2 1 2 3 Application Overview 10 8 6 4 2 1 2 3 Operate the instrument 10 8 6 4 2 1 2 31 Evaluate results 10 8 6 4 2 1 2 3 Maintenance 10 8 6 4 2 1 2 3 Troubleshooting 10 8 6 4 2 Legend Importance Level 1 Very important 2 Important 3 Not so important Satisfaction Level 10 Extremely satisfied 8 Very Satisfied 6 Satisfied 4 Unsatisfied 2 Very unsatisfied Missing features to be implemented other comments or suggestions Edif Instruments s r l Via Ardeatina 132
2. 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 The form in the next page regards the Customer s satisfaction you are kindly requested to fill this anonymous questionnaire and to return it to the following address EDIF INSTRUMENTS S r l Via Ardeatina 132 00179 Rome Italy Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 CUSTOMER S SATISFACTION QUESTIONNAIRE ENERAL OPINION ON INSTRUMENT S PERFORMANCES Importance Specific Performance Satisfaction Mark il fo 3 Pipetting 10 8 6 4 2 11 2 3 Reading 10 8 6 4 2 1 2 3 Productivity throughput 10 8 6 4 2 1 2 3 Tests Programming 10 8 6 4 2 1 2 3 Software User interface 10 8 6 4 2 Legend Importance Level 1 Very important 2 Important 3 Not so important Satisfaction Level 10 Extremely satisfied 8 Very Satisfied 6 Satisfied 4 Unsatisfied 2 Very unsatisfied Missing features to be implemented other comments or suggestions Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1
3. 28 Chlorides 2 Alhunre ipi 32 User Test There are three steps to execute the assays Test Selection Controls Selection and Standards Selection Those steps are detailed in the following paragraphs Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 5 1 1 Tests and Control Selection In this section the operator must confirm the controls and select the tests To confirm all the selected tests without the controls press the F1 button Continue To choose the tests press the F2 button to choose the controls press F3 button move the cursor through the columns with the following buttons A Move up y Move down E Move left Enter Move right Select or deselect the test control with the F4 button To switch all the controls on press the F5 button In the line with the method the number of the tests to effect and the position of the control is indicated C1 to C9 if a control has been inserted in the parameters After this operation press the F1 button to go to the Standardization procedure Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 5 1 2 Standardisation Procedure In this section the operator must select the standards to use The methods are classifie
4. Up to 27 positions for reagent bottles e Up to 64 seats for sample vials e 96 positions for incubation tubes 1 flow cell for reading is available e Urgent Access capability e Adaptability to a wide variety of tests available on the market Result data evaluation through proved interpolation methods Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 4 2 Principle of Working The ECHO executes programmed tests in the following two manners with optimised times Batch Mode for all the patients Urgent Patients one by one For the Batch Mode the ECHO is working according to the following principles every cycle is composed of a complete wheel 96 wells For every cycle it is possible to insert up to 96 wells Including also the first well for the blank reagent of each method a well for each standard a well for each control and a well for each test For each test you can programme 27 reagents the tests with 2 reagents will take 2 places Each method is executed completely in one cycle the maximum per method is of 64 sample test The cycle is programmed for methods that don t use more than 96 wells The methods over this limit will be executed in the successive cycle At the end of execution the ECHO will sign it with 3 bips and will come back to the execution menu to ask for the ne
5. 09 Cholesterol 10 Triglycerides 13 Tot Protein 14 Chlorides 17 Abumin 18 4 Amylase 21 Cholimesterase 22 Inorg Phos 25 Magnesmm 26 C K M B 29 Carbonate 30 Blood Sugar fig 7 6 7 Type the number of the patient to repeat the code of the test and the auto dilution parameter Press F1 to activate the test repetition If the patient doesn t have that test programmed the ECHO will inform you with a beep If there are several tests activated for the patient these will be signed as urgent Program an auto dilution in case the sample is concentrated or if the results are not linear In this case during the execution the sample will be diluted as defined in the methodology Chemicals Method Edition The activated tests will appear in bold Repeat the operation for all the tests to execute Press Pg Up BackMenu to exit or to change for another patient Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 6 4 Controls Pressing the F5 button in the Results menu fig 7 6 1 will be showed the following screen fig 7 6 8 VALUES OF THE CONTROLS Test 1 EEES DATE DATE VALUE DATE AS ab t oh ato f OS AS ES ES ato l l l OS l l oh af 09 04 2003 119 0 AS 10 04 2003 118 0 ato 11 04 2003 119 0 af ah AVER 118 6 STD 4634 C
6. 7 8 1 Reagents Consumable and Toxic Reagents consumable and toxic must be dismantled according with regional laws All waste materials must always be treated as potentially infected materials see par 1 4 3 Information on Infectious Liquids and Parts 7 8 2 Instrument and Components The dismantling of the product should be carried out by applying the local regulations referring to the local environment authority taking into consideration that the instrument is manufactured with no noxious materials for the environment but during the usage it could be contaminated with infected materials see par 1 4 3 Information on Infectious Liquids and Parts Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 8 MAINTENANCE 8 1 8 1 1 8 1 2 User Maintenance Basics This section will provide the user with general recommendations for the periodical maintenance WARNING Failure to follow the maintenance procedure could compromise the performance of the system e Keep the ECHO work area clean and free of debris Spills on working surfaces should be wiped and rinsed immediately with water Continuous instrument inspection is critical for optimum equipment performance e All waste materials should be disposed of according to accepted safety guidelines and local regulations
7. The principles are the same as the ones described in the Batch mode For the successive patients the initial washings and the auto zero procedure are not effected The blank reagent is executed only for the first patient on whom the method was programmed Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 4 3 Bibliography Alon R Bayer E A and Wilcheek M J 1990 Streptavidin contains an RYD sequence which mimies the RGD receptor domain of fibroneetin Biochem Biophys Res Commun 170 1236 1241 Brinkley M 1992 A brief survey of methods for preparing conjugates with dyes haptens and cross linking reagents Bioconjugate Chem 3 2 13 Chan D W Immunoassay Automation Academic Press Diamandis E P and Christopoulos T K 1991 The biotin strep avidin system Principles and applications in biotechnology Clin Chem 37 5 625 636 Engvall E and Perlmann P 1971 Enzyme linked immunosorbent assay ELISA III Quantitation of specific antibodies by enzyme labeled anti immunoglobulin in antigen coated tubes J Immunol Methods 10 161 170 Gosling J P 1990 A decade of development in immunoassay methodology Review Chn Chem 36 1408 1427 Harlow E and Lane D eds 1988 Antibodies A Laboratory Manual Cold Spring Harbor Laboratory Cold Spring Harbor NY Ishikawa E Hashida S
8. Verify the water used for the reconstruction of the lyophilised reagents serum controls Verify the reagent preparation in accordance with the instructions of the producer Control the peristaltic pump tube and eventually substitute the same Controls that the tubes are not broken or clogged Control the pump assembly Shut down the instrument and turn it on after few seconds Call the technical assistance Verify the thermal paper its insert and the absence of blocks Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 9 6 Competence Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 10 TECHNICAL SPECIFICATION 10 1 Instrument Technical Specification ECHO s technical characteristics are listed in the sections below 10 1 1 Sample Loading e Sample tubes on sample plate 64 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 10 1 2 Sera and Reagent Pipetting Station e Syringe Dilutors e Syringe Resolution e Carry Over 10 1 3 Incubating Station e Incubating area 10 1 4 Photometric Reading e Reading range e Reading
9. connected to a 220 Vac or 110 Vac power socket Installation On customer demand the installation verification and calibration of the instrument will be carried out by qualified technical personnel They should take reasonable steps to ensure that the location in which the equipment is to be installed meets the environmental and electromagnetic specifications for the analyzer Any significant movement of the equipment should be carried out by qualified personnel If the instrument has the refrigerated plate option a free air space of at least 10 cm is necessary to allow air cooling inlet placed on the bottom of the instrument on the left side Operations If the ECHO is used for automated clinical chemistry analysis the Manufacturer reminds the Users that failures following safety precautions and regulations could produce false negative results reporting For these reasons particular care must be carried out by the operator to the following points e Use only test procedures or assays pre validated by the Manufacturer or its distributor e Don t introduce any modification on pre validated procedures or assays Avoid to use vials other then Manufacturer suggested types Particular care must be observed for the instructions provided by the Manufacturer in order to perform correct switching on and off procedures Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 06512755
10. 1 4 3 3 Eventual tools and instruments used during technical intervention must be sterilised before putting them back into their cases Dismantling All waste materials including both liquids and solid must be dismantled according with regional laws and local regulations WARNING The Manufacturer remarks to the user that all waste materials must always be treated as potentially infected materials In case of replacement of faulty parts each broken parts dismounted from the Instrument just by manufacturer or local distributor qualified personnel must be handled as potentially infected materials The Manufacturer declares that all technical personnel have exceed a specific training course related to infected materials treatment WARNING All parts dismounted from the Instrument that could have been entered in direct contact with possible contamination sources must be subjected to a valid decontamination process before leaving the User s medical laboratory The dismantling of the product should be carried out by applying the national regulations referring to the local environment authority taking into consideration that the instrument is manufactured with no noxious materials for the environment Contamination Risks of contamination exist only during the operations of loading unloading with regard to this see section 1 4 3 Information on Infectious Liquids and Parts During the instrument operation there are not cont
11. 14 with 2 controls 1 13 with 3 control These are the positions from 1 to 16 in which the user should place the standards in case of mono standard methods This is the start position from 1 to 16 in which the user should position the standard samples defined by the 11 parameter standard number in case of multi standard methods The standards should be placed in side by side increasing positions If the last standard position is over the position 16 this will cause an error Control Position Range 1 16 This is the position where the user should place the controls See parameter 12 number of controls Standard Value Range 0 000 99999 This parameter will appear only when the number of standards is 1 This is the theoric value of the standard used in case of mono standard methods A null value will cause an error when the factor is 0 is necessary to evaluate a new standard Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 17 7 3 1 18 Factor Range 0 000 99999 This parameter will appear only when the number of standard is minor or equal to 1 For the mono standard or with no standard methods the factor value is multiply for the optical density to have a result The user should insert the factor in case of methods without standard Descriptio
12. 3905 2 0 3 0 4 0 PREVIOUS FRINT ti Control 12 3 fig 7 6 8 The ECHO memorizes up to 30 values of control of 32 32 tests When a new control is executed the ECHO will re write the new values on the old ones if the date is the same If the date of the last control is different it will be added to the controls In the fields on the bottom of the screen are detailed AVER Average value of the memorized controls values Average STD gt n number of controls n CV gt Percentage of SD AVER Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 To select the method press F1 to select method typing its number F2 allows the selection of the successive methods 1 32 F3 allows the selection of the previous methods 1 32 With the F4 button is possible to print the controls and the selected methods the F5 button allows to erase the controls of the selected methods F6 visualizes the Levy Jennings graphics F7 to setup theoretical the minimum and maximum value of the control sera t Control 1 2 3 pressing the we can choose to visualize the quality control of the normal abnormal low and abnormal high control sera Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC
13. CTRL FEED Selection of all the standard in option OFF To confirm all the parameters press F1 The programming of the work execution can take up to 3 seconds the opening of a window After this operation a working cycle table will appear on the screen fig 7 5 4 Usedtubes 039 065 062 034 Wash tubes 38 Used tube segments 2 3 Method Pos ral Val Glucose 100 0 Calcium 10 GOT i 1746 Cholesterol 200 0 Triglycerides E 200 0 Creatinine 2 000 Uric Acid 6 000 Tot Protein y 1 000 Lypase 2000 Please place the reagents to correct position change segments START EXECUTION SETSTART TUBE PRINT PAGE fig 7 5 4 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 In the first line of the screen is showed the number of the tubes to use in the second line there is the number of the rack to use then in the third line there is the number of the test to execute In the seven columns are detailed the method name the reagent position R Pos the reagent volume 2 ml Val ml the execution with factor F or mono multi standards S with the standard s position the standard or factor value Val the position of the control Ctl Pos the relation between standard and reagent volume S R The operator should control if everything is placed in the right order with t
14. In case of faulty or broken instrument parts repair or replacement should be performed immediately by qualified technical support personnel e Read carefully the information on infectious liquids appended to this manual see Section 1 Competence Any repairs adjustments or replacements of parts should be carried out by Technical Support Personnel only Daily weekly and monthly routine maintenance procedures must be carried out by the user designated to operate it Cleaning The plates and the working area should be cleaned using a soft cloth Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 8 1 3 8 1 3 1 8 1 3 2 WARNING Before using any cleaning or decontamination method except those recommended by the Manufacturer users should check with the Manufacturer that the proposed method will not damage the equipment Disinfections This section covers the description of the indispensable information about instrument disinfection WARNING Read the Safety Section 2 very carefully before coming out any maintenance For all the disinfection activities wear a protection overall with long sleeves ending with rubber bands resistant rubber gloves and protection glasses Prepare two Sodium hypochloride solutions commercial hypochloride one at 1 and the other at 0 5 Generally commercial h
15. Rel 1 1 1 6 How to Use this Manual The Manufacturer recommends to read this User s Manual in any of its parts in particular it is necessary to take care of notes used to specify or to probe concepts previously treated and of warnings used to emphasize potentially risks or hazards All the notes and warnings written in bold print must be read carefully paying particular attention to the following sections e Safety Chapter 1 Installation Chapter 3 Maintenance Chapter 8 During Laboratory daily operation it is also suggested by the Manufacturer not to keep this User s Manual too far from the ECHO instrument Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 1 7 Index of Contents Section i INTRODUCTION 1 1 1 2 1 3 1 4 1 5 1 6 1 7 Identification Dat ita airada Ll Document nan AA eh I Be See Ass 112 strument eee A A taa 1130 MantlaclUl es AS IEA Ci COP ideo International and European Norms Compliance ooococcnoccnoccnccconononcnnncnncnnnonnnons A NN Document Intended PIP dos How to Use this Mandala ii dt Index of Contents ii a aa av helio Ne Aik ds aS ed he Gd Section 1 SAFETY 1 1 1 2 13 1 4 1 5 General Wan A a a Safety Labels ieena ano a a e a a a a Satety Warning S iaro a E E A E tian se te a E aE ESA Instala a E tt E E A ET 132 O
16. Rel 1 1 7 2 2 If the master analyst has forgotten his password after typing a wrong password for analyst 0 the ECHO will display a key number and wait for a master password The master analyst must call the assistance give the key number and get back the master password This master password will clear Analyst 0 password and give access to the instrument only once The TEST TOTALS displayed in the CONTROLS menu are in release 3 xx separated per analyst The values displayed are only the tests executed by the selected analyst Anlyst 0 can display the totals for all the analysts Main Menu Once user has type his password fig 7 1 1 will be displayed the following screen fig 7 2 1 MAIN MENU ECHO AUTOMATIC ANALYZER ISE EDIF Firmware version x xx EXEC UTON LESULI CHEMISILIES FELVICE fig 7 2 1 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 From this screen is possible to have access to the five main software sections by pressing the corresponding key F1 WORK LIST Allows the access to the patients manager section F2 EXECUTION Allows to run the assay procedures F3 RESULTS This button gives the access to the result section F4 CHEMISTRIES The Chemistries section allows to edit modify print a chemistry method or to set up a new method F5 5 f The serv
17. User manual Rel 1 1 7 7 Urgent Analysis To introduce an urgent sample during a cycle it is necessary to stop momentarily the cycle by pressing the Esc Stop button The following message will be showed fig 7 7 1 STOP REQUEST RECEIVED STOP aberi ENTER centimos l fini curia iy anly fig 7 7 1 The ECHO will inform you by a 10 seconds beep signal during this gap the user can proceed as follows Esc Stop This button will block the instrument and the execution will be lost Enter The execution cycle will continue 1 The best choice the instrument will finish the tests in course and will be ready to take the urgencies NOTE The urgency is inserted with the standard procedure Work list in the Patient Edit menu press 0 button do not erase the previous patients then in the Execution menu press F2 button Urgent At the end of the urgency cycle the instrument will inform you with a beep then it will return to the Execution menu press 1 button Batch mode to restart the stopped cycle 7 8 Dismantling For the disposal of liquids parts of the instrument and the instrument itself the user must refer to the local regulation and to the law recommendations To dismantle liquids and parts read carefully the following sections Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1
18. a free air space of at least 10 cm Software The ECHO software is a firmware multitask application purposely realized for this instrument it has characteristics of reliability and use facility It is recorded on the two EPROMS mounted on the CPU board An internal mini PC with a DOS Terminal program is used for the video keyboard external printer and host interface Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 3 3 Storage To store in the right way the instrumentation it is recommended to store it in a dry area and to observe the storage environmental requirements listed in section 10 6 Remember that the instrument must be stored exclusively in its original wood packing and that the operations for the storage must be carried out only by authorized personnel Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 3 4 3 4 1 3 4 2 Unpacking Before proceeding to unpacking the instrument check that all constrains and environmental conditions are met refer to section 10 Technical Specifications Package Characteristics ECHO is normally despatched in a box made of cardboard studied to give the best protection to the instrument during transportation in normal conditio
19. a small range adapting it to the cycle of the instrument For the methods with 2 reagents this time minimum is the one between the sampling of the first and second reagent Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 4 7 3 1 5 7 3 1 6 7 3 1 7 7 3 1 8 Stabilization Time Range 1 60 seconds It is the time between the pipetting in the measure cuvette and the reading This time is necessary to allow the thermo stabilization and turbulences stabilization Reading Time Range 1 254 seconds This is the measure time The sampling A D converter has a frequency of 200 m sec The sum of the readings during the measure time gives the result Reagent 2 Incubation Time Range 12 9999 seconds Set this value different from 0 if method works with two reagents end point bi chromatic kinetics or fixed time It is the time between the pipetting of the reagent 2 and its reading In case of Incubation Time this is the distribution time between the reagent and reagent 2 Reagent Position Range 1 27 It is the position of each reagent assigned by the user ECHO has 27 positions for the reagents and can work on 27 mono reagents methods for each plate The methods with 2 reagents are using 2 consecutive positions reducing in this way the number of simultan
20. b gt lt i gt 32 19 GLU BUNK BT CALGPT lt D9 lt 1 lt L gt lt 12 gt lt lt 145 lt 3 gt lt 1 gt lt 175 lt 95 aS 14 GLU GOT GPT fig 7 4 9 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 5 Operative Procedure To have access to the Execution menu press F2 button in the main menu screen fig 7 2 1 the following screen will appear on the monitor fig 7 5 1 Note it is possible to enter into the Execution Menu only in case there is already a Work list in memory EXECUTION Methods panel 1 03 09 OP 449 C Cuv 38 1 C F1 Time Optimized Batch per test all samples F2 Urgent sirgle sample all tests F3 Automatic samples dilution F4 Automatic standards dilution OPTIMIZED BATCH URGENT DILUTE SAMPLES DILUTESTANDARD SETTME fig 7 5 1 Batch mode ECHO processes all the patients optimizing the times Urgent mode ECHO analyses the sample one by one Automatic sample dilution ECHO dilutes the patients for which the pre dilution has been requested on the Work List patient Automatic standard dilution ECHO dilutes the concentrated standard to create the necessary standards to produce the calibration curve For the Optimized Batch mode F1 button the ECHO work according the following principles Every cycle is composed of a complete whee
21. himself that all Instrument technical activities related to installation performance verification and repair are carried out by qualified personnel All precautions and recommended practices normally used in the laboratory Good Laboratory Practice must be followed this is particularly important because the diagnostic tests are carried out automatically by the analyzer Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 1 2 Safety Labels Infective tank warning This label is placed on the external tank for the waste and near the peristaltic pumps It informs the user about the contamination risk for the part where it is placed ATTENZIONE SERBATOIO POTENZIALMENTE INFETTO WARNING POTENTIALLY INFECTIVE TANK Electrical risk warning This label is placed on the back of the instrument and it informs the user about electrical risk WARNING HIGH VOLTAGE INSIDE DO NOT OPEN CABINET REFER TO QUALIFIED PERSONNEL Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 1 3 1 3 1 1 3 2 Safety Warnings To reduce the risk of electric shock keep away from live circuits The instrument must be connected to a ground point The instrument is equipped with a three core cable to be
22. is s le o 000 fig 5 3 5 3 1 3 Reaction Plate This plate fig 5 4 has 4 positions for inserting disposable racks with 24 reaction tubes for each one so the total capacity is 96 tubes fig 5 4 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 5 3 2 5 3 2 1 5 3 2 2 5 3 2 3 5 3 2 4 5 3 3 Pipetting Subassembly Sampling Needle The mechanical arm with the sampling needle moves on the plates and for each test first picks up the reagents then takes the serum or standard control from the serum cup in the inner plate Then the needle sends out all the liquid to an incubation tube Aspiration Needle After the incubation time this needle will aspire the liquid from the tube to the flow cell for measurement A needle performs three aspirations for each test The first and the second aspiration will not remain in the cuvette and will be transferred to the waste bottle This will be useful to wash the liquid residues of the previous sample from the fluidic system avoiding carry over results The third aspiration volume will be kept inside the cuvette and measured for the reading time selected by the method After reading this liquid will be thrown away thus clearing the flow cell for a new measure Syringe The syringe can aspire in two different ways depending to the pos
23. method e Reading filters 1 dilutor with n 1x1ml precision syringes 3000 steps on max stroke Metal needle lt 10 ppm with 1ml wash volume 1 room 4 racks 96 wells 0 3 00D Single double or double beam with over range filter vertical reading 8 interference filters Standard supply is 340 405 492 505 546 578 630 700 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 10 2 Adjustement and Settings No settings are required from the instrument User All mechanical and electronic adjustments must be performed by technical personnel Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 10 3 Electrical Requirements e Voltage 110V to 240V manual setting e Frequency 50 60 Hz Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 10 4 Operating Environmental Requirements e Temperature 15 C to 35 C e Humidity 20 to 80 RH not condensing e Altitude 0 to 2000 meters Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A E
24. point bi chromatic and differential uses the blank reagent Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 29 Factors and Curves Selection Is possible to choose between two options see fig 7 3 8 1 ERASED daily 2 values are KEPT EDIT METHODS Methodsn 1 gt gt Type Endpoint GLUCOSE Filte rxs 505 nnm Code GLU Sample Volume uL Reag 1 Volume uL Reag 2 Volume uL Reag 3 Volume uL Number of Washes Stabilization Time s Reading Time s R1 Incubation Time s Position of reagent Number of standards Number of controls 1 Position of standard Positionof Control 16 Factor and curve Standard value 100 0 Factor 0000 2 Values are KEPT Dilution Ratio in Rep 6000 Sample dilution 0 Linearity 600 00 N of decimals 4 R Blank Value rain 0000 max 1000 Normal Value min 65 00 max 110 0 mg dl gt Blanks are used in calculations gt The factors is KEPT in memory SELECTMETHODS NEXT METHOD PREY METHOD SELECT OPTION NEXTOPTION fig 7 3 8 Choosing option 1 the factor is not stored When a standard is analyzed the calculated factor is noted in the parameter 16 factor and is used for the successive sample but it is discharged after the instrument shut down Choosing option 1 the factors are automatically stored When a standard is analyzed
25. s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 Plate Blank Procedure steps Processing Mode Serial dispensing Stepping motor Waste tank liquid in the wells at the end of the reaction Blank value subtracted from all other values read on the microplate Step by step instructions for a test run It refers to the selection of parallel or serial dispensing A processing of the first plate up to the first incubation and then proceeding to the second plate Special motors used for precise movement Tank where all the contaminated liquids are disposed Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it
26. showed the patient number in the ID column there is the ID code of patient followed by the list of the selected tests number 1 to 32 For the urgent patients the work list is visualized in bold If the work list is longer than what appears on the screen press a key to continue and press ESC to terminate NOTE The tests are visualized per code or per number Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 4 4 Print Work List Pressing the F4 button in fig 7 4 1 the software allows to print the work list see fig 7 4 8 Press the F1 fig 7 4 8 button to print all the patients list or press the F2 fig 7 4 8 button to print only the urgent patients list 7 4 5 Print Profile List Pressing the F5 button in fig 7 4 1 the software allows to print the profiles list see fig 7 4 9 PROFILES LIST OLD BON CAL GOT OPT lt 11 gt 2 GLU BT lt 13 gt lt 19 gt lt gt J GLI CAL GOT GPT lt 13 gt 3 lt 12 eip lt llo cis lt dd gt 25 et gt lt 31 gt 32 gt t 3 3 4 OLU CAL GOT lt ie lt td gt cil gt ct lt 19 gt lt 14 gt 3 a BT CAL lt 07 gt lt 05 gt 499 lt LL gt lt 12 gt 2135 14 gt lt 17 gt 2195 lt B gt 423 gt lt gt lt 27 gt 428 gt lt 31 gt lt 37 gt 10 BT CAL lt 07 lt io lt 11 gt lt i2 gt lt 15 lt 14 gt 12 6252 lt dd gt lt
27. step programming e Fast and accurate printout of test results e Reduces the risk of human error Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 5 3 Functional Subassemblies The ECHO is based on the following functional subassemblies Pipetting subassembly Flow cell Spectrophotometric reading subassembly The subassemblies are described in the following sections 5 3 1 Working Area The working area fig 5 1 contains fig 5 1 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 5 3 1 1 Sample rack primary tube location Reagent rack for 27 standards tanks Reagent Plate This plate is located on the left side of the working area end it has 27 positions for the reagent bottles so it is possible to contemporarily execute a maximum of 27 different methods fig 5 2 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 5 3 1 2 Sample Plate This plate fig 5 3 is placed in the middle of the instrument working area and it has 64 holes for inserting serum cups with blank samples standards and controls le o Oe es
28. the calculated factor is noted in the parameter 16 factor and can be used for the future analysis Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 4 Patients Handling Pressing the F1 button in the Main Menu fig 7 2 1 the following screen will appear fig 7 4 1 ECHO AUTOMATIC ANALYZER ISE EDIF Firm ware version x xx B PROGRAM LOAD WORKLIT DISPL WORKLIST PRINTWORKLIST PROFILES LIST fig 7 4 1 The available options are the following Keybord Program by pressing F1 allows to program the patient work list by the keyboard Load Work List by pressing F2 with is option is possible to load a work list from an external PC using the serial port RS232 Display Work List by pressing F3 displays the work list on the monitor Print Work List by pressing F4 allows to have a printout of the work list Profiles List by pressing F5 to display on the monitor the profiles list Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 4 1 Edit Work List Pressing the F1 button the software show three options fig 7 4 2 Clear previous patients O No 1 Clear only test 2 Clear all fig 7 4 2 Press 0 button to not delete the existing
29. the Curve a a eat 7 3 1 20 Substrat Dep RI E A A ts 7 3 1 20 bis Sample dilution A acs son ia eae aadd ehiee aes ARANDA O a O 7 3 1 23 Reagent blank value TM a 7 3 1 24 Reagent blank value MaX o dida 31 25 Normal Valte O tds IE US Is isean hnnan a acta 731 27 Measure Uiit SEIS AAA eae a meus enn imma nee stoneenes 7 3 1 28 Washings Number ii on 7 3 1 29 Blank Reagent Selection ira ic Patient A e ee do FAA Edit WOK AS as ish Oc a ec a aa tet oe 4 2 AISA Work isaac da TAS Display Work Distritos TAA PI o O NUS TAS PU e tetera a aie Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it 20 20 20 Al cal 522 Za 25 26 31 32 33 33 34 36 37 38 El1121A Echo PC User manual Rel 1 1 ESAS EXPO id 7 5 1 4 Automatic sample dilution is 7 5 1 5 Automatic standard dilution a ee T r RES dica ToL Display Results 2 A 102 Print Results pcnsi iaa a a SS 7 6 3 Rep ttions e 7 6 5 1 R petition of One Testa enia 7 6 3 2 Repetition of One Paleta is TOA E Dnia o K T A E T hol Urgent Analysis e EA Me Dismantling zes anena a Me Tau M2 ec la ede en ted lel E EN a 7 8 1 Reagents Consumable and TOXIC s ccaiesccs tiene it dais 1 8 2 Instrument and Components inicie cias Section 8 MAINTENANCE 8 1 User Maintenance Basics iaa Skl Competente einn E R a ale Bald O A A Eaa Aaa aan ERE EAIiE 8 1 3 1 Instrument Di
30. 0 email edif edif it El1121A Echo PC User manual Rel 1 1 1 3 3 1 3 4 NOTE The Manufacturer reminds to the User that safety precautions failure could produce human hazard risk or damages both for operator and patient Maintenance The User must carry out the maintenance procedures quoted in Chapter 8 in order to assure a correct operation of the instrument and the reliability of the assay results NOTE The Manufacturer remarks to the User that continuous Instrument visual inspection is the first and easier way to guarantee the best equipment performances User s maintenance tasks must observe the following safety recommendations e Read carefully the instruction on Chapter 8 before starting with maintenance e Clean every part of the Instrument only using soft cloths e Remove immediately spills or sketches from the working planes if any Use only non corrosive solutions WARNING All User maintenance tasks must be carried out with the Instrument in OFF state and with the main power cable disconnected from the power socket Transport and Storage Take care during the transport and the unpacking of the instrument To store the instrument read carefully Section 10 6 Storage Environmental Requirements Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 1 4 1 4 1 Risks R
31. 0210A S1001000011 Flow cell temperature sensor 1 El0211A S1001000010 Outer reaction plate temperature sensor 1 El0212A S1001000009 Diluter stepper motor 1 El 0213A S1001000012 Optical pre amplifier assembly 1 El0218A S1001000017 2 Boards interconnection flat cable 2 El 0220A S1001000019 Reagents plate rotating wiring kit 1 El0222A S1001000021 Optical signal cable 1 El 0223C nd Low voltage wiring assembly AMPMODU MATE N LOCK 1 El 0223B S1001000022 Low voltage wiring assembly old MX396 connectors El 0224B S1001000023 High voltage wiring assembly 1 El0226A S1001000025 Stepper motors protection diodes modules 8 El0301B2V1 nd Power board AMPMODU green connectors 1 El 0301B2 S1001000026 Power board MX396 old white connectors El0O302B1V1 S1001000027 CPU board 1 El 0302B1 nd CPU board old version with CRT controller El 0214A S1001000013 Internal printer assembly 1 El 0307B S1001000028 Power supply transformer assembly 1 EI10401A S1001000031 Power supply for reagent cooling 1 El 0245B S1021000013 Level sensor module 1 El 0109C S10 2100 0012 Internal PC PC104 assembly 1 11 4 Ordering Information Refer to your local distributor Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 Web www edif it email edif edif it El1121A Echo PC User manual Rel 1 1 11 5 Technical Assistance The Technical Assistance will be provided through your local distributor
32. 04 04 Calcium 03 Alkaline Phos 12 Une Acid 16 Acid Phos 20 C K NAC 24 L D H P 25 Magnesium 29 Alburnine fig 7 5 5 In this screen are detailed the following information Execution Number of tests to execute Wells used Number of wells used for the cycle execution The first one is the well used for the washings Total time Time to execute the cycle min and sec time to programming the work execution in sec Final time Remaining time to the end of the work cycle min and sec Well The last well used for the sampling Sample Standard sample Cycle t Time to effect a simple cycle in 100 of sec Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 5 1 4 7 5 1 5 Automatic sample dilution To run the automatic sample dilution in case there is at least one patient with the pre dilution activated in the work list press the Key F2 Execution from the Main Menun and then press F3 Automatic sample dilution For ex In case the patient n 1 Daniele has in the work list activated the dilution in percentage follow the below procedure Put an empty serum cup in the position n 32 of the sample plate the available positions for the dilutions are starting from the position 32 of the sample plate Put a reagent bottle in the position 27 with distilled water
33. 1 El 0802A P10 0000 0010 Sampling and Aspiration needles kit 1 Halogen calibrated lamp with support MATE N LOCK EI0O703CV1 149 0000 0023 connector 1 El 0703C P10 0000 0011 Halogen calibrated lamp with support old MX396 connector El0701B nd Fuses kit 115V 1 El 0702B P10 0000 0012 Fuses kit 230V El0719A P10 0000 0013 Diluter Syringe complete of plunger 1 El 0832A P10 0000 0015 Flow cell quartz O ring kit old flow cell 2 El0102A P10 0000 0016 Heating reel 1 El0721A P10 0000 0017 Water charge bottle 1 El 0722A P10 0000 0018 Waste bottle 1 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 Web www edif it email edif edif it El1122A Echo PC Maintenance manual Rel 1 1 ECHO PC SPARE PARTS QTY ON EDIF CODE OLD CODE DESCRIPTION BOARD El 0201A S1001000001 Optical limit switch 7 El 0202A S1001000002 Cooling fan for power board 2 El 0244A nd Bottom cooling fan 1 El 0203A S1001000003 Diluter solenoid valve 1 El 0204A S1001000004 Peltier cell for optics 1 El O0205A S1001000005 Heating etched foil resistance outer plate 1 El 0206A S1001000006 Heating etched foil resistance pre heating reel 1 El0207A S1001000007 Sampling and aspiration needle step motors 2 El 0208A S1001000008 RP IP OP FS PM stepper motors 5 ElO
34. 1 1 Porstmann B and Prstman T 1988 Chromogenic substrates for enzyme immunoassay In Non isotopic Immunoassay T T Ngo ed pp 59 84 Plenum Press New York Roberts I M Jones S L Premier R R and Cox J C 1991 A comparison of the sensivity and specificity of enzyme immunoassays and time resolved fluoroimmunoassay J Immunol Methods 143 49 56 Wilchek M and Bayer E A 1988 The avidin biotin colmplex in bioanalytical applications Anal Biochem 174 1 32 Van Weemen B K and A H W M Schuurs 1971 Immunoassay using antigen enzyme conjugates FEBS Letters 15 232 236 Yalow R S and Berson S A 1959 Assay of plasma insulin in human subjects by immunological methods Nature 184 1648 1649 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 5 FUNCTIONS 5 1 5 2 Intended Use The ECHO is an analyser designed to automate Clinical Chemistry tests The ECHO is designed to automate a great part of operations of the long and borings laboratory routine analysis It ensures more accuracy and precision of the output more productivity and more safety for the operator In this way ECHO assures saving of time and money In addition to the traditional in vitro diagnostic testing that includes hormones drugs of abuse etc this instrument can be used for a great numbe
35. 1 El0703CV1 P10 0000 0023 Halogen lamp MATE N LOCK connector 1 El 0801B P10 0000 0008 Tubes kit 1 El 0802A P10 0000 0010 Sampling and Aspiration Needles kit 1 ElO710A P10 1000 0001 Reagent bottles 25 ml 27 pos pack 30 pcs 1 ElO711A P10 1000 0002 Reagent bottle caps 25 ml 27pos pack 30 pcs 1 El 0714A P10 0000 0003 Needle cleaning filters pack 1 ElO715A P10 0000 0004 Reaction segments pack 100 pcs 1 ElO716A P10 0000 0005 Serum cups pack 1000 pcs 1 El0717A P10 0000 0006 Thermal paper pack 3 pcs 1 El 0702B P10 0000 0012 Fuses kit 230V 1 El0721A P10 0000 0017 Water charge bottle 1 El0722A P10 0000 0018 Waste bottle 1 EEO203A S10 2100 0009 Null modem host cable 1 El 0702B P10 0000 0012 Fuses kit 230V 1 El 1126A Brief user manual 1 El 0732A Documentation CD 1 EEO202B Power cord ECHO PC CONSUMABLES EDIF CODE OLD CODE DESCRIPTION PACK EI10710A P10 1000 0001 Reagent bottles 25 ml 27 pos pack 30 El0711A P10 1000 0002 Reagent bottle caps 25 ml 27pos pack 30 El0712A P10 0000 0001 Reagent bottles 40 ml 18 pos pack 20 El0713A P10 0000 0002 Reagent bottle caps 40 ml 18 pos pack 25 El0714A P10 0000 0003 Needle cleaning filters pack 25 El0715A P10 0000 0004 Reaction segments pack 100 El0716A P10 0000 0005 Serum cups pack 1000 El0717A P10 0000 0006 Thermal paper pack 3 P10 0000 0007 Tubes kit old over with vertical diluter 1 El 0801B P10 0000 0008 Tubes kit 1 El 0822A P10 2000 0003 Flow cell new model 10 x 10 mm
36. 1121A Echo PC User manual Rel 1 1 1 4 2 1 4 3 1 4 3 1 Personal Safety Aspect The Manufacturer declares that the Instrument and all its internal parts were designed and manufactured to prevent any possible risk for the operator safety It is mandatory for the operator safety to install an emergency breaker at not more than one meter from the Instrument Information on Infectious Liquids and Parts The use of the instrument doesn t assure the absence of exposure to biohazard The Manufacturer remarks to the User that all parts of the Instrument that could come into direct contact with blood or sera including positive controls and or reagent must always be treated as potentially infected materials WARNING The instrument must be always handled as potentially infected device Handling When handles potentially contaminated sera the operator must wear Lab coat Disposable gloves Safety glasses in order to avoid splashes and or spilling of the infectious liquids that could come into contact with any exposed part of the body Take special care when you handle the following parts of the instrument e Metal needles Waste tank because they could be contaminated they come in contact with sera and reagents Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 1 4 3 2
37. 12 GLOSSARY 12 1 List of Acronyms and Abbreviations ASTM American Society for Testing Material Standard transmission format for host communications AU Absorbance Units Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 List of Terms Peristaltic pump Absorbance Autodiagnosis Barcode Beam Blank Blanking Calculus Engine Database Default Dilutor pump End Work Fill syringes Halogen lamp HTML format Incubating station Interference filters Interpolator Login Logoff Maintenance Metal needle Multiplication factor Optical sensor Over range filter Parallel dispensing Password Photometric reading system Device required by ECHO to aspirate liquid from the working area to a self contained reservoir It is related the colour intensity of a liquid Light passing through a dark liquid is absorbed A self investigation or analysis of the cause or nature of a condition situation or problem Information that has been encoded in a bar and space format A ray or shaft of light Result value equal to no reaction Reference value of the light intensity used to measure the absorbance of the liquid in the wells A data processing program A set of stored data used for search and retrieval Value or Document which is standardised specific This unit ensures precise and accur
38. 2 ODm ODr ODm 100 lt 2 Linearity The linearity test has the purpose to verify the linearity of the optical group photometer detector plus preamplifier The test is performed using the concentrated solution of Potassium Bichromate with a nominal O D of 0 250 0 500 1 000 2 000 mAbs at 340 nm wavelength The four solutions are read with the instrument in the O D test menu F5 SERVICE F3 DIAGNOSTICS F2 O D TEST for direct immediate optical density reading The solutions are aspirated directly in the cuvette pulling out the aspiration needle After the execution of the four tests it is necessary to calculate the correlation index 1 2 3 4 Concentrations Cd C2 C3 C4 Ci 0 250 0 500 1 000 2 000 nominal value Opt Densities OD1 OD2 OD3 OD4 ODi Vcc n Sce Se Sc ci Scc ci Voo n Soo So So ODi Soo O Voc n Sco Sc So Sco iG ODi Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 6 3 6 3 1 Correlation index R Voc V Vee Voo To accept the test the correlation index must be higher or equal to 0 95 NOTE The linearity and the correlation index can be calculated automatically and the graph can be printed using the instrument s curve calculations A special user test must be edited with N of st
39. 2 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 Is possible to choose the result measure unit select the appropriate one from the EDIT METHODS Methodsn 1 GLUCOSE Code GLU Reag 3 Volume uL 3 Cycle 12 Number of controls 1 Position of Control 16 Sample dilution 0 1000 110 0 mgfdl SELECT OPTION NEXTOPTION 7 3 1 26 Measure Unit Selection windows that appear on the screen fig 7 3 6 Use F4 button to select the option and F5 button to go to next option Endpoint 505 nnm Sample Volume uL 4 Reag 1 Volume uL 5 Reag 2 Volume uL 500 Number of Washes 2 Stabilization Time s 4 Reading Time s R1 Incubation Time 3 Position of reagent Number of standards Position of standard Standard value Factor Dilution Ratio in Rep 6000 Linearity 600 00 N of decimals 4 R Blank Y alue min 000 max Normal Value min 65 00 max gt Blanks are used in calculations gt The factors is KEPT in memory SELECTMETHODS NEXTMETHOD PREV METHOD fig 7 3 6 7 3 1 27 Washings Number Range 1 13 typical 2 For the high density reagents use 3 or 4 For creatinine iron calcium use 5 This is the number of the vials and syringe washing carried out after the sampling and the number of washings of the flow cell carried out at the end of the measure For the last washings instrument uses 1000 micro liters
40. 3 Allows to load the results and the working list on a SEND RESULTS PC F4 To organize the repetition by test or by patient REPETITIONS F5 This function allows visualizes prints or erases the CONTROLS memorized values of the tests and controls Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 6 1 Display Results Pressing the F1 button in the Results menu fig 7 6 1 will be showed the Result Report menu fig 7 6 2 RESULTS REPORT LD John Brown Result Result A Amylase 9 999 g dl 9999 g dl lt L GOT 9999 g dl GPT 9 999 zi dl Creatinine 9999 g dl lt L Alkaline phos 9 999 g dl lt L Acid phos 9999 g dl Cholesterol 9 999 2 41 lt L Tot Iron 9 999 g dl lt L Tot Bilirubin 9 999 eid Calcium 9 999 gi dl Triglycerides 9 999 g dl Uric Acid 9 999 g dl Tot Protein 9 999 g dl Gh cose 9 999 e dl D Bilim bin 9 999 g dl Chlorides 9 999 2 41 The F4 and F5 buttons allows to choose the visualization mode by patient F4 or by test F5 The F2 and F3 buttons allows to display the next or previous patients tests With the F1 button is possible to choose a patient or a test simply typing the patient test number in the Patient Test field on the top of the screen Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 emai
41. 5 Storage Environmental Requirements ooconincccnonoconoconnconncconoconnconoccon cnc nocnnnnonnos 10 67 A AE E E E E E A erga 10 7 Electromagnetic Compatibility oooooocnnncnincccionoconononnconncconoconn cono nonn coco nocnnncnnnos 10 8 CONSUMO ie Section 11 SUPPLEMENTARY INFORMATION 11 1 11 2 11 3 11 4 11 5 11 6 Short Users A e e A Warranty Limitations ns acari ee OS el Spare Parts and Consumables ii illa Ordering formations sekesi ias e s Technical Assistance inncan moarden hann n i a a h a E a bis Section 12 GLOSSARY 12 1 12 2 List of Acronyms and Abbreviations sessesesesseeesseesesstsetsesseseesssssestesesseseese ERROIA N Crise erst E AAA ot Sve Ne As at as da Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it VD 0 A Dn bh NY NN DD Gu A W N Rh o n El1121A Echo PC User manual Rel 1 1 1 SAFETY Id The safety precautions and regulations included in this section must be strictly observed by the User The use of the Instrument for purposes other than those specified in Chapter 5 will automatically invalidate any warranty agreement The user must not carry out any kind of alteration on the Instrument included software manipulations Every unauthorized change or modification and not observance of the maintenance procedures will immediately invalidate warranty agreements Genera
42. Echo PC User manual Rel 1 1 6 PERFORMANCE CRITERIA AND LIMITATIONS 6 1 General Statement This section provides information on the performance of the instrument that need a peculiar approach to measure them being based on statistic or indirect method measurements This paragraph provides the statement for these items Precision It is the concordance between the repeated measures it gives the ability of the instrument to reproduce the same value when handling the same quantity Accuracy It is the ratio between the expected value of the parameter and the true value Linearity Let us assume that the measured values of an ideal instrument are on a straight line the Linearity is the shifting from this ideal straight line of the real instrument measures The first photometer precision accuracy and linearity tests are executed in the O D TEST function FS SERVICE F3 DIAGNOSTICS F2 O D TEST and are necessary to validate the photometer The pipettor precision accuracy and carry over tests are executed running a simplified method and use the photometer as the test instrument to validate the pipettor The tests use a kit of four reference solutions of Potassium Bichromate with the following nominal O D at 340 nm wavelength e 2000 mAbs 1000 mAbs e 500 mAbs 250 mAbs The solutions are calibrated by the SYSTEA Srl laboratory using a spectrophotometer UV VIS JENWAY mod 6405 accuracy of 0 1 The real certi
43. El1121A Echo PC User manual Rel 1 1 ECHO USER S MANUAL Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 i INTRODUCTION i l Identification Data This document represents the User s Manual of the ECHO an automatic multi parameter analyzer for clinical chemistry The document has to be intended as a functional part of the ECHO analyzer instrument and the user must read carefully all the sections of this manual before operate with the instrument The manufacturer doesn t take any responsibility related to partial or unauthorized copy of its contents 1 1 1 Document e Document Part Number EI1121A e Document Revision Rel 1 1 e Dated 03 07 2008 e Software Version Rel 4 23 e Release Date 2008 1 1 2 Instrument e Instrument Part Number EI0002A 1 1 3 Manufacturer Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 email edif edit it 1 2 Copyright This document is property of Edif Instruments S r l Unauthorized copies or alterations of its content could cause legal actions in order to preserve manufacturer s interests Edif Instrumen
44. Kohono T Ad Taka K 1988 Method for enzyme labeling of antigens antibodies and their fragments In Non isotopic Immunoassay T T Ngo ed pp 27 55 Plenum Press New York Johannsson A Stanley C J and Self C H 1985 A fast highly sensitive coloribetric enzyme immunoassay system demonstrating benefits of enzyme amplification in clinical chemistry Clin Chim Acta 148 119 124 Kabakoff D 1980 Chemical aspects of enzyme immunoassay in Enzyme Immunoassay E T Maggio ed pp 97 98 CRC Press Boca Raton FL Kricka L J 1993 Ultrasensitive immunoassay techniques Review Clin Biochem 26 5 325 331 Kricka L J 1994 Selected strategies for improving sensitivity and reliability of immunoassays Clin Chem 40 3 347 57 Pesce A J Krieger N J and Michael J G 1983 Theories of immunoassay employing labelled reagents with emphasis on heterogenous enzyme immunoassay In Immunoenzymatic Techniques pp 127 138 Elesevier Amsterdam Pesce A J and Michael J G 1992 Artifacts and limitation of enzyme immunoassays J Immunol Methods 150 111 119 Review Peterman J H 1991 A Summary of the principle immunoassay data analysis packages In Immunochemistry of Solid Phase Immunoassay J E Butler ed pp 293 297 CRC Press Boca Raton FL Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel
45. NEXT METHOD PREV METHOD SELECT OPTION NEXT OPTION fig 7 3 5 7 3 1 19 Substrat depletion Range 0 000 99999 This parameter is used only kinetic and fixed time type methods If the difference between the optical density of the first reading and the optical density of the blank reagent is greater than the value of the substrat depletion the following message will appear Substrat depletion Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 20 Dilution Ratio Range Max 1 0 typical 0 5 0 25 When at the end of a cycle is requested a repetition of a test with an automatic dilution the sample volume is multiplicated by the dilution ratio and the reagent volume is increased to compensate the reduction of the sample volume Sample vol x dilution ratio Reagent vol Sample vol x 1 dilution ratio NOTE it is not possible to use sample volumes after dilution inferior to 3 micro litres 7 3 1 20 bis Sample dilution 7 3 1 21 It is possible to pre dilute the sample in case of patients with chronicle diseases for example diabetes or for the determination of the Creatinuria This dilution is done with the physiological solution or distilled water The function has three options 0 Does not accept pre dilutions 1 Accepts the pre dilution and the result is not treate
46. Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 1 3 3 7 1 3 4 7 1 3 5 7 1 4 Preservation To avoid in vitro alterations that could modify analysis result the sample must be preserved according to specific reagent manufacturer instructions The general instructions to preserve samples are the following Serum or plasma centrifugate the vial with the blood after coagulation in case of serum put serum or plasma in another vial and refrigerate till the test Urine prepare a sample in a 10 ml vial and refrigerate till the test Sample Minimum Volume It is the dead volume plus the volume needed to carry out the analysis Dead Volume If the sample volume is less or equal than dead volume the needle can t aspirate it The sample dead volume for standard tubes is lt 100uI this may be reduced using vials with conical shape at the bottom They need to be properly calibrated by Technical Service personnel Reagent and Disposable Materials Reagents are the materials that interacting with sera generate the reaction at the various step of the procedure The reading of the final colour supplies the analysis outcome Disposable materials are vials and disposable needle cleaning filters Reagent can be loaded in polystyrene tubes 24 ml It is recommended to not reuse reagent vials NOTE The information about Reagents and Disposable Materi
47. a aacnaeees Gad VOM E EA cade auaslhs sosuealaebesiedecaueeteeces 7 1 4 Reagent and Disposable Materials ooonoonnnccnnnconocococcconnnconncnnn cono ncon coco nocnnnos 7 1 4 1 7 1 4 2 VIS A A AA E EN A Preservation eem ern RE Gs 7 1 5 Fixture and Accessori Senni e ar E A A E E a a 7 2 Management System cOVE Westin iia Pode How A ns besa capac a anunnadaecuneaoa sees pameudted baa EE ee A E A A 7 3 Chemiustries MED LL A e E Tada Edit Method SL AA A A 7 3 1 1 7 3 1 2 7 3 1 3 7 3 1 4 7 3 1 5 7 3 1 6 7 3 1 7 7 3 1 8 Types Selections A A A PRICES A o A Incubation A A eat eS aa Stabilization A A A A Reading AA II eda S Reagent 2 Incubation Time dd dns A A A atucel ee tat Ri Reagent Volume dia iii Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it VD N A DA A an A bh A A WW uu NY NY Rh 2 uu Ro a a a a a Pa papa KR hh A A A Q W N O El1121A Echo PC User manual Rel 1 1 Foo AO RD Reagent VOM A ici TIALO RS Reagent Vv ONMINE i a s ToL Sample Volume A A a E as 7 3 1 12 Numbers of Calibration Standards conconcnncnnnnnncnocnncncnnnconcconcnnnonncnns 7 3 1 13 Numbers of Controls iaa 7 3 1 14 Standard Position aia Tal tS Control Posi Onenen ne e a ill gas oe tye A A eet oi bon L6 Standard Valtere e dee te ci TE IR A Are EE E E E A AT Fa AAS N mMmber Of CUTVES rapidito artir aa ais 7 3 1 19 Description of
48. ad 63 Work list loading completed ECHO AUTOMATIC ANALYZER ISE EDIF Firmware version x xx IKEYB PROGRAM LOAD WORK LIST DISPL WORK LIST PRINT WORK LIST PROFILES LIST fig 7 4 6 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 4 3 Display Work List Pressing the F3 button in fig 7 4 1 the software allows to display the work list see fig 7 4 7 WORK LIST Pat LE 1 Brown 125087 GLO BON BT C L OOT OFT iir aj apir a Dee cjl a pe de digr cj fe ciii cf fee Ae 2 QLU BUM BT CAL GOT OPT atti abe eter oper jjs da lar tLe O 7s sga 0 lt 0 SLU BUH BT CAL GOT OPT 907s dies ee 02 lt gt e 2 4 Lie a gc Ts sga Xp GLU BUH BT GAL GOT GFT D7 alt appe sge F 2 2 Lie abir cj Te fda of ie lt a ALU BUM BT CAL GOT OPT eit oie ciie oper cf fe ep ol Se ele tS ler Te la oie ce SLU BUH BT CAL GOT OPT lt 07 gt dis 906 lt gt 0 gt Lb Lie LG el is 2125215 xp GLU BUH BT CAL GOT OPT aT 218 ee lt 0 gt lt gt lt 2 2 L5 ES QLU EUN BT CAL GOT DPTO rr flo ld rl tiir cj Te lc fee be FLU BUN BT CAL OT OPT atti ll le e fo e da eje eG lira e la cji ce SLU BUH BT CAL GOT GPT 07 gt ait appe 0 gt lt lt 01d lt L5 gt 62 0 7s lt l3 gt 015 lt p GLU BUH BT CAL GOT OPT 9072 dite 906 alg a lt lt L5 gt yt rae ES deg fig 7 4 7 In the Pat column is
49. al density of the standard sample from the beginning of the test executions and will calculate the factor The factor will be positioned in standard position and will have a defined value standard value From 2 to 8 These values are used for non linear methods immunology In this case the ECHO will calculate with the number of curves and the description of the curve The length of the curve is equal to the number of the standard this should be positioned in increasing order starting form the position defined by the standard position See also the Standardization Procedure Par 7 4 1 2 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 3 1 13 7 3 1 14 7 3 1 15 7 3 1 16 Numbers of Controls Range 0 3 The ECHO allows to store up to 30 values of control for each method on one level The control should be requested by the user during the execution time see tests and controls to execute If this parameter is 0 you can not execute or memorise any control If this parameter is 1 a control will be executed at the beginning of the execution of the corresponding methods immediately after this a possible standard The control sample should be placed in the position defined by the 14 parameter control of position Standard Position Range 1 16 1 15 with 1 control 1
50. als quoted in this is general We strongly recommend to read carefully the instruction of their Manufacturers Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 1 4 1 7 1 4 2 7 1 5 Use Preparing the reagents before or during the test procedure depending on their stability Reagents and samples should be at room temperature 18 25 C before beginning the assay and can remain at room temperature during testing All containers used for preparation of reagents must be cleaned thoroughly and rinsed with water before use Preparation of reagents and controls these must be free from froth or bubbles on the surface of the liquid or inside the test tubes or vials Use only disposable needle cleaning filter of the manufacturer s specified type Preservation To preserve reagents and disposable material user must follow carefully manufacturer instruction Fixture and Accessories For the list and the description of ECHO accessories see Chapter 3 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 2 7 2 1 Management System Overview The ECHO software runs with DOS operative system and it is simple to use The system is provided with pre validated test procedures these
51. amination risks because the instrument in this step doesn t need the user intervention Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 1 5 Recommendations for Optimal Performance The User must observe the following recommendations in order to get the specified performance from the instrument e Fill sample vials out of the instrument in order to avoid spilling of liquids on the ECHO working area The user must ensure that when placing test tubes or vials into the analyzer these are properly seated e If the laboratory does not have back up power supplies a standby system UPS providing at least 1 5 kW should be used to provide power during short term cuts WARNING Use of the instrument for purposes other than specified indicated or agreed upon with the manufacturer will automatically invalidate all warranties The manufacturer reserves the right to take any legal action to protect all its interests Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 2 SYMBOLS No symbols are applied on this version of ECHO Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC Use
52. andards 4 or 8 if the solutions are read twice Calculation mode linear regression e Curve values O D and std values taken from the test results Pipettor Precision This test evaluates the repeatability of the reading of a concentrated solution dispensed through the ECHO pipettor It is performed evaluating the CV of a series of readings of the same solution and compared with the CV of the photometer obtained with test 1 It is necessary to prepare a special test method e type end point e sample volume 100 reagent volume 400 reagent position 1 incubation time 0 sec The test is performed repeating n 8 times the reading of the concentrated solution of Potassium Bichromate with O D 2 000 mAbs at 340 nm wavelength The concentrated solution is put in the first 8 sample cups 1 8 and distilled water is put in reagent position 1 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 6 3 2 After the execution of the eight tests it is necessary to calculate the CV So i0Di Soo ioDpi Vm So n Voo Soo n Vm n 1 CV VVoo Vm 100 The acceptance level of the CV is lower or equal to 5 Accuracy The test is performed comparing the O D obtained diluting the reference solution with the instrument s pipettor and the O D obtained diluting the refere
53. ate delivery of samples or reagents by means of a syringe Option to safely shut down the laboratory analyser This feature enables a pipettor dilutor cycle the The cycle will have the effect of purging any air bubble out of the hydraulic system Lamp used to generate the light required during the reading step A standard format for internet pages Temperature controlled micro chamber Calibrated filters used to distinguish the colorimetric reaction generated by enzymatic reaction Calculus program for regression analysis Enables the access to the system via Password Disables the access to the system Operation required weekly and monthly to clean and assure a good functioning of the analyser One of the two devices used for pipetting standards and samples Correction factors used when the optical density is out of limits and used in conjunction with an over range filter Electronic device on the receiving end of the photometer to convert light into electronic signal Reading filter used when the reading exceeds the 2 OD limits and if it is foreseen in the reagent kit instructions It must be used in conjunction with the Multiplication Factor Simultaneous processing of plates up to first incubation A sequence of characters required to access to computer system or to an application System consisting in a light source discriminating filters and sensors It is used to measure the colour intensity of the Edif Instruments
54. cho PC User manual Rel 1 1 10 5 Storage Environmental Requirements e Temperature 10 C to 35 C e Humidity 5 to 95 RH not condensing e Altitude 0 to 9000 meters Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 10 6 Emissions No risks related to gas emission implosion or explosion of parts is present Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 10 7 Electromagnetic Compatibility The instrument complies with the standard EN60326 A1 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 10 8 Consumptions e Power 300 VA typ Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1122A Echo PC Maintenance manual Rel 1 1 11 SUPPLEMENTARY INFORMATION 11 1 Short User Instruction Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 Web www edif it email edif edif it El1122A Echo PC Maintenance manual Rel 1 1 112 Warranty Limitation Edif Instruments S r l warran
55. d as follows STANDARDIZATION PROCEDURE TESTS to standardize 05 G O T 09 Cholesterol 10 Triglycerides ins 12 Uric Acid 13 Tot Protein Tot 16 Acid Phos 17 Potassium eE 20 C K NAC 21 Cholines erase Soda 24 L D H P 25 Magresum 2 Albumre fig 7 5 3 The standard must be executed The standard can be executed as an option The standard is not necessary The standard must be executed but it can not be done error Entering into the standardisation procedure the standards that should be executed are already signed in bold The operator can not cancel the selection but can only select the standards to execute as optional Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 The standard must be executed when The method has a defined standard the value of the standard is different from zero the factor is zero The method is defined as multistandard and the values of the O D curve are zero The standard can be executed as an option The method has a defined standard the value of the standard and the factor are different from zero The method is defined as multistandard and the values of the curve are different from zero The standard is not necessary e The method does not require a defined standard and the factor is different from z
56. d mathematically for ex Pre diluted at 50 the final result will at 50 2 Accepts the dilution and the result is treated mathematically for exp Pre diluted at 50 the final result will be calculated multiplying by 2 Linearity Range 0 000 99999 If the result is greater than this value the following message will appear Not linear result The test should be repeated with the diluted sample see repetitions Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 22 7 3 1 23 7 3 1 24 7 3 1 25 Reagent blank value min Range 0 000 99999 If the optical density of the blank reagent is minor to the value determined by this parameter the following message will appear Blank out of range Reagent blank value max Range 0 000 99999 If the optical density of the blank reagent is greater than the value determined by this parameter the following message will appear Blank out of range Normal Value min Range 0 000 99999 If the result of a test is minor to the value determined by this parameter on the screen after the value the symbol will appear Normal Value max If the result of a test is greater than the value determined by this parameter on the screen after the value the H symbol will appear Edif Instruments s r l Via Ardeatina 13
57. database 1 button to clear the tests but not the patients in the database and 2 button to clear all database After a choice will be displayed the following window fig 7 4 3 EDIT WORK LIST Date 17 05 95 Urgent edit Of 1 0 Methods panel methods panel 2 1 First sample 1 Last sample 54 Fast programming tests for all samples Input test list 123456 Fast programming profile for al samples Input profile list 1 2 3 EDIT PATIENTS TESTS LST PROFILES LIST fig 7 4 3 In this screen there are some information about the programmed work list and in particular Date Urgent Edit Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 o 0 corresponds to a normal edition all the patients will be treated in the same way o 1 first will be treated the urgencies the patients codifies as Urgent e Methods Panel allows the selection of one of the two groups each one with 32 methods e Firs Patient up to 63 samples the first patient number correspond to the position number on the sample plate Last Patient up to 63 samples the last patient number correspond to the position number on the sample plate e Input test list this numbers separated by a dot identify the tests that will be executed for all the patients for fast programming only Profile test list this numbers
58. e instrument At least two persons are needed to move the instrument from its box to the working table Lift the instrument up and place it on the working bench the one on which the instrument is destined to be operated upon Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 Hardware Installation 3 5 1 3 5 2 ECHO is a sophisticated high precision instrument A correct installation will assure the good functionality of the instrument We suggest to execute the installation by the technical staff of the I S E S r l or by staff trained by I S E S r l and make sure to carry out a complete start up of the instrument before operation For detailed safety instructions read carefully Section 2 Electrical Connection In compliance with the safety precautions listed at the beginning of this manual to reduce the risk of electric shock the instrument should be connected to a ground point The instrument is equipped with a three core cable for connection to a 220 V or 110 V power socket Therefore connect the power cord situated on the back of the instrument to a 115 or 230 VAC 50 60 Hz grounded receptacle NOTE Although ECHO is equipped with an internal stabilised power supply it does not manage temporary power losses The installation of backup equipment with a power rating of 1 5 kW to be supplied to the l
59. edif it El1121A Echo PC User manual Rel 1 1 7 3 1 2 7 3 1 3 Filter Selection In the Filters field fig 7 3 4 is possible to set the photometer filter The available filters will appear in a window on the right of the screen in case of bi chromatic methods the program will ask for a second filter The ECHO has 10 filter positions the position 0 is EDIT METHODS Method n 2 Type Fixed time UREA Filters s 340 nm Code BUN Sample volume ul 5 Reagent 1 Volume uL 500 Reagent 2 Volume uL 0 Reag 3 Volume ul 0 Number of washes 2 Stabilization time s 13 Reading Time s 17 Cycle 36 R1 Incubation time s 72 Position of reagent 2 Number of standards 1 Number of controls 1 Position of standard 2 Position of Control 16 Standard value 50 00 Factor 633 1 Susbstrate depletion 7000 Dilution Ratio in Rep 6000 Sample dilution 0 Linearity 200 0 N of decimals 4 R Blank value min 8000 max 1 800 Normal Value min 15 00 max 50 00 mg dl gt Blanks are NOT used in calculation gt The factor is KEPT in memory SELECT METHODS NEXT METHOD PREV METHOD SELECT OPTION NEXT OPTION f or the offset readings Note In case of Bichromatic analysis the instrument will ask you to memorize a second filter Incubation Time Range 12 9999 seconds This represent the foreseen time of the reaction This is the time between the sampling and reading The software can modify this time in
60. elated to the Use The Manufacturer reminds that the use of the Instrument doesn t assure the absence of exposure to BIOHAZARD so the Instrument must be always handled as potentially infected device The Manufacturer declares that information provided through this manual have to be consider sufficient to perform a free of risk usage of the referred equipment only in case of readers that previously exceed a manufacturer s specific training course To reach the full throughput condition of the Instrument and to assure at the same time the user safety the Manufacturer recommends considering both the operator and the patient point of view that the daily operators have to be also previously trained to the operating system basic usage The Manufacturer also assumes that all precautions and recommended practices normally used in the laboratory Good Laboratory Practice must be applied by the Instrument operators NOTE To avoid running additional risks do not make any unauthorised modifications any kind of alteration should be made with the prior authorisation of the manufacturer Human Hazards Particular safety items against human hazards are the following Do not eat drink or smoke in the laboratory e Wear the lab coats at all time and particularly near the Instrument placement point Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El
61. eous methods in use The user should assign 32 positions to reagents in two test groups table 1 table 2 We suggest to assign in each group an exclusive positions for the most frequent and usual tests and to reserve the other positions for the rare methods or to the other tests which are rarely simultaneous If there are two application with the same position in use the analyzer will change the position of the method with the major incubation time R1 Reagent Volume ul Range 5 800 Typical 400 500 It is the reagent volume in micro liters Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 9 7 3 1 10 7 3 1 11 7 3 1 12 R2 Reagent Volume ul Range 5 800 Typical 5 50 It is the second reagent in micro liters This value must be set to 0 for the mono reagent methods A value different from 0 indicates a method with 2 reagents R3 Reagent Volume ul Range 5 800 Typical 5 50 Sample Volume Range 5 500 It is the sample volume in micro liters Numbers of Calibration Standards Range 0 8 This value indicates the number of standards used for the calibration 0 Value calculated with a factor A missing factor will cause an error I If the value of the factor is 0 during the analysis cycle the ECHO will measure the optic
62. ero The standard must be executed but it can not be done error The method has no defined standard the factor is zero The test can not be executed The method has a standard with a defined value the factor is zero and the value of the standard is zero The following message will appear on the line 21 ERROR Method xx standard value null The test can not be executed The method is defined as multistandard and one or more values of the n standard is are zero The following message will appear on the line 21 ERROR Method xx N std Xx Curve n x The test can not be executed If you select a standard for a method which does not require it the ECHO will inform you with a beep signal Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 In fig 7 5 3 you can use the following buttons F2 Visualizes the programmed tests per reference F3 Visualizes the factors Under every method name is showed For the methods without standard Factor 0 Ex F 1746 For the methods with one standard The standard and factor position are 0 Ex S1F1000 For the methods multistandard First standard position and number of standards Ex S1x8 The number of the curve Ex Curv 13 F4 Selection and selection cancellation one by one F5 Selection of all the standards in option ON DEL
63. es and then carefully rinse it with deionised water User Maintenance Warnings Work only with the instrument off and the power cable disconnected Serious damage to the vacuum pump can occur if there is too much fluid in the condensation trap User Daily Maintenance Procedure Daily maintenance consists in the following steps e Thorough rinsing of the ECHO analyser s hydraulics will prevent the formation of salt crystal that can clog tubes and valves Wipe up and disinfect any spills on the working area e Remove all reagents from the reagent plate Wash the plate in case of spills Disinfect if material is potentially contaminated Remove all sample tubes from the sample plate Wash the carousel with disinfectant in case of potentially contaminated spills Please read carefully the following important recommendation e Inspect the instrument for leakage and spills Should you find any remove the liquid promptly Refer to Section 1 on infectious liquid Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 8 4 User Weekly Maintenance Procedure In addition to regular daily maintenance the following weekly decontamination procedure is recommended The weekly decontamination may vary according to instrument use and is therefore user defined You have to carry out all the steps listed T
64. f it El1121A Echo PC User manual Rel 1 1 7 1 3 7 1 3 1 7 1 3 2 Sample Handling To ensure a correct use of the instrument and to increase the reliability level of the analysis results it is important to read the following information Samples preparation samples must be adequately brought to room temperature and checked to be free from clot fibrin froth or bubbles The presence of clot and fibrin may cause incorrect dispensation of sample NOTE The information about Sample quoted in this is general We strongly recommend to read carefully the instruction of the assay Manufacturers WARNING In case that the ECHO is used for fully automated medical In Vitro Diagnostic IVD analysis the Manufacturer remind to the Users that failures to follow correct sample handling procedures could produce false negative results reporting Sample Type ECHO can be used for fully automated in vitro diagnostic analysis utilizing samples like blood serum plasma urine and any liquid solution coming from a sample preparation NOTE it must be validated that the pipetting system is able to handle the viscosity of the liquids loaded as samples when they are resulting from a sample treatment preparation Pre treatment To avoid in vitro alterations that could modify analysis result the sample must be preserved according to specific reagent manufacturer instructions Edif Instruments s r l Via Ardeatina 132 00179
65. ficated O D values of the reference solutions are employed in the tests calculations Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 6 2 6 2 1 6 2 2 Photometer Precision This test evaluates the repeatability of the reading It is performed evaluating the CV of a series of readings of the same solution The test is performed repeating n 8 times the reading of a concentrated solution of Potassium Bichromate with an O D of 2 000 mAbs at 340 nm wavelength After the execution of the eight tests it is necessary to calculate the CV So 2ODi Soo 210Di Vm So n Voo Soo n Vm n 1 Cys Woo Vm 100 The acceptance level of the CV is lower or equal to 2 Accuracy The accuracy test of the photometer is performed together with the precision test measuring the average O D of a reference concentrated solution of Potassium Bichromate with an O D of 2 000 mAbs at 340 nm wavelength So Diopi ODm So n Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 6 2 3 This value obtained with the instrument in O D TEST F5 SERVICE F3 DIAGNOSTICS F2 is compared with the O D reference value The difference between the two values must be lower than
66. g the information provided with a test kit The software is password protected with a defined password that can be modified only by the authorised user see the Configuration Section 5 4 1 Software Architecture In the following paragraphs are described the main functions of ECHO software that allow to set test and use the instrument 5 4 1 1 Main Menu The Main menu enables the user to access the five main software features described in the next paragraphs 5 4 1 2 Work List Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 5 4 1 3 5 4 1 4 5 4 1 5 5 4 1 6 This section allows the user to program the patients database and to set the tests list for each patient Execution This option gives the access to the section that allows to start the analysis procedure Results This option allows to display print and send the results report of a test session Chemistries This software section is used to edit modify print or create new assay procedure Service The Service function allows to initiate the calibration procedures Only specialised personnel have access to this section of the software See Service Manual p n for details Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A
67. he correct volumes and if the reagent segments rack are correct The operator can change the initial bottle with the following procedure press the F2 button and digit number 1 then Enter The working cycle will start automatically from the segment 1 the first well of the segment is always reserved for the washings After all the controls have been carried out press F1 button to start the execution 7 5 1 3 Execution When the execution starts on the screen will be showed a series of tables that allow to monitor the instrument operation The first table is the nitial Washing one then will be showed the Auto Zero Procedure table a control is executed on the filters used for the programmed methods Furthermore other tables will indicate by analysis in bold which operation is in execution in particular e Sampling or control or test Standard incubation or control or test Standard reading or curve or test Washings The following image fig 7 5 5 shows an example table Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 Processing 142 tests Used tubes 039 169 040 160 Total time 39 00 Time to end Reag Level 24 ml 01 Glucose 05 G O T 09 Cholesterol 13 Tot Protein 17 Potassium 21 Choliresterase Next tube 37 40 Sampling blank Cycle t 11
68. horough rinsing of the ECHO analyser s hydraulics will prevent the formation of salt crystals that can clog tubes and valves Empty the used tips tray disinfect and wipe dry e Wipe up and disinfect any spills on the working area Clean the exterior of the metallic needles if in use with 70 ethanol Check that the metallic needles are firmly in place e Remove all disposable cups and reagent containers Inspect the reagent plate tray for spills leaked solutions or salt crystals Rinse with distilled water and wipe dry Disinfect if material is potentially contaminated Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 9 TROUBLESHOOTING 9 1 Normal Operation Basics 9 2 Diagnostic System 9 3 Trouble Sources Classification Remarks 9 4 Correct Operations Messages Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 9 5 Error Messages List and User Required Actions Generic error codes Problem Possible Causes Actions Syringe module not connected No reagent and sample sampling and pa Sapling tube broken Sampling tube not connected Pinch valve not functioning Empty bottle Washing solution is not dispensed Defective valve Control the tubes co
69. hsstuazaaheciaccabandantsseatenstatevsaubaesttastis pag 9 43 Removal From Pagkage laicos pag 3 3 Hardware goenscntes pag 3 5 1 Electrical CONAECUONS a e vias Watatery Seeded ro pag 3 5 2 Instrument Installation Procedure ooooocnoconocinonoconononononononnncconocannconn coronan pag 3 5 3 LN pag A eat ensayo ath ten ko scat och R Naess pag A RO pag 360 SoftWare Installation sa daa pag 3 6 1 Requirements and Recommendations oooocooccocccooccnonnconnoconocnnn cono cconcccn nacion pag Section 4 THEORY OF OPERATION Ml a aa pag 4 2 ARO pag 43 BUDO OPA aaneen oes agen le dake cs aula a aae ede aera aut ase A pag Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it wo 0 NQ N A A ann A Q Q Q Q N N N Ra ua o o El1121A Echo PC User manual Rel 1 1 Section 5 FUNCTIONS Intended Vii ii iia Sais ala sa Instrument Functions Overview ococccononononononnnnnnnnnnnnnnnononononononononononononononinininnns Functional Subassemblies cococonononononononononnnnnnnnnnnononononononononononononononinininons Sl Working Ara tiran SILL Reagent Plat esla isla ota LA Plate A as 5 3 4 3 O 3 3 2 Pipetting SUDASSEMDLY ii A A Anse aaees 5 3 2 1 Sampling Needle sees tease ceive a A 9 3 2 2 Aspir tion sde 5 3 23 a eo Ded 20 POTTS PUDO SANA E E soars Dede FOW A A A O 5 34 Spectrophotometric Reading c c csec
70. ice section access is reserved to authorized personnel only SERVICE Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 Chemistries Menu In this section is detailed the procedure to modify the parameters of a test section From the Main menu fig 7 2 1 press the F4 button the following window will be displayed fig 7 3 1 CHEMISTRIES MENU ECHO AUTOMATIC ANALYZER ISE EDIF Firmware version x xx EDIT METHODS PRINT METHODS LOAD DUMP METH PROFILES PANEL 1 PANEL 2 fig 7 3 1 From this screen is possible to have access to the following six sections pressing the corresponding key F1 Allows to edits the methodologies a Allows to print the tests methodologies Print Methods F3 This button allows to import methods from an external PC F4 Profiles To enter in the Profiles menu F5 To select Panel 1 Clinic chemistries or Panel 2 Panel 1 2 Turbidimetry with 32 tests each one Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 3 1 Edit Methods To enter in the Edith Methods menu press the F1 button in fig 7 3 1 the following screen will be showed fig 7 3 2 01 Glucose 05 G 0 T 05 Cholesterol 13 Tot Protein 17 P
71. is very important that the user must know the details of the User s Manual additionally he needs to be trained according to the manufacturing procedures to the use of the instrument for operations The user can t approach to the software s sections protected from passwords out of his competence Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 1 2 Instrument Set up Switch on the instrument on the screen will appear the message fig 7 1 1 INITIALIZATION ECHO AUTOMA TIC AN ALYZER ISE EDIF Firmware version xxx PRESS A KEY TO START fig 7 1 1 Press a key and wait until the initialization is performed It controls the correct functioning of the principal instrument subassemblies In case of malfunction will appear an error message on the screen Prior to load the materials required for the instrument run consisting in reagents test supports samples etc carry out the following steps Empty the waste tank this must be usually performed on instrument shut down Check that tanks for the distilled water are filled 7 1 2 1 Instrument Built in On Line Test The self test of the instrument is performed automatically at the instrument start up Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edi
72. ition of the electro valve located on its top it can aspire from the water bottle or from the sampling needle The movements of this component regulate the aspiration and the ejection from the sampling needle and allow cleansing of the tubes and all the fluidic system with distilled water Peristaltic Pump The peristaltic pump can perform a number of steps in the third aspiration reading aspiration variable from the first and the second one The number of steps can be modified by user user parameters to allow a greater or a lower aspiration in order to reach the exact position of the liquid front in the inlet tube Flow Cell This component is located under the little metal door of the instrument It has inlet tubes coming from the aspiration needle and outlet tubes that going to the peristaltic pump at the waste bottle Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 5 3 4 Spettrophotometric Reading Photometric reading is performed by a spectrophotometer The liquid is automatically transported to the reading stations An internal microprocessor controls the 9selectable interference filters The system measures the optical densities mono or bichromatic reading of each test The principle on which is based the photometric reading is the Lambert Beer law An incident wave shooting a solution that hold
73. l 96 wells For every cycle is possible to insert up to 96 wells including the first well for the blank reagent of each method a well for each standard a well for each control and a well for each test Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 For each test you can program up to 27 reagents the tests with 2 reagents will take 2 places Each method is executed completely in one cycle the maximum per method is of 64 sample test The cycle is programmed for methods that don t use more than 96 wells The methods over this limit will be executed in the successive cycle At the end of execution the ECHO will sign 1t with 3 bips and will come back to the execution menu to ask for the next cycle until the execution of the entire programmed test e During the cycle the end point methods including the bi chromatic ones are distributed for first and will be measured at the end of the incubation time During this interval the Fixed Time methods kinetics and differentials are executed The ECHO will begin the sampling of the tests of one method waiting the incubation time When the incubation is terminated the instrument reads the incubated sample and does a new sample alternatively If the cycle is composed only by End Point methods the same operational mode is used to increase the exec
74. l Warnings All notes and warnings in this Manual which are in bold and or underlined must be read carefully paying particular attention to the following sections Installation Section 3 Disinfections Procedures Section 8 All assay methods must be validated on the analyzer before carrying out any laboratory routine Such validation must include Make sure that the instrument correctly handling the various reagents with reference to o Aspiration transfer and distribution of the liquid o Liquid mixing if required without bubble or froth formation which may create problems in later stages of the process Reliability of materials used for the procedure sample tubes reagent and or control vials microplates etc Accurate calculation ensure that the software calculations give results comparable to those obtained using the methods specified by the assay manufacturer These procedures are normally validated by the distributor if the required data are not available for any particular assay the user must validate these procedures himself Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 Any modification made to pre validated procedures must be validated again The User should always check the proper closure of the Instrument covers during the use of the instrument The User must always assure
75. l edif edif it El1121A Echo PC User manual Rel 1 1 7 6 2 Print Results Pressing the F2 button in the Results menu fig 7 6 1 will be showed the Print Patients Report menu fig 7 6 3 PRINT RESULTS First sample 1 Last sample fig 7 6 3 Now insert in the fields the First and the Last patient which should be printed Press the key F1 Print PRINT RESULTS First sample 1 Last sample Form feed after every sample 0 No 1 Yes fig 7 6 4 Choosing 0 the patients will be printed in sequence without heading choosing 1 we will have a patient report complete of heading printed on the external printer NOTE The patients which have no results will not be printed Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 6 3 Repetitions After the execution of a tests cycle the operator can ask some repetitions to be done There are 2 functions to use Pressing the F4 button in the Results menu fig 7 6 1 will be showed the following screen fig 7 6 5 F1 Repeata test all patients F2 Repeata test single patient fig 7 6 5 With this menu the operator can carry out some repetitions after the execution of a tests cycle Two functions are available pressing the F1 button will repeated one test for all the programmed patients With the F2 button will be repeated one tes
76. le 1 EE0203A S10 2100 0009 Null modem host cable 1 El0702B P10 0000 0012 Fuses kit 230V 1 El 1126A Brief user manual 1 El0732A Documentation CD 1 EEO202B Power cord Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 3 2 3 2 1 3 2 2 3 2 3 Installation Constrains During the installation of the ECHO the operator has to observe mechanical and environmental constrains in order to assure a correct instrument operation Mechanical ECHO should be positioned on a working bench at least 1 meter long free of vibrations and far from electromagnetic sources big electrical motors elevators therapeutic equipment X rays etc and with a good ground connection The working bench must be a robust table to prevent the oscillation of the instrument the table should be as flat as possible and capable of bearing the weight of the instrument Environmental The place where the instrument will be installed should be possibly an air conditioned room to have a firm temperature and a correct degree of humidity Avoid the direct exposure to the sunbeam Allow a working space around the instrument of at least 50cm However if space facilities are restricted and the instrument has the refrigerated plate option the air intake located on the bottom of the instrument on the left side must have
77. le blank PREV METHOD SELECT OPTION NEXT OPTION fig 7 3 3 The position of the cursor indicates if a parameter is opened for modification or not Note The 5 parameters indicated by are opened by a sub menu selection in a window on the right side of the screen that appears when the cursor is positioned on one of the parameters The parameters are detailed in the following sections To exit from the Edit Methods menu press the PgUp button or the Ese button then press F1 to not save the modifications or F2 to save the modifications To print the chemistries press the F2 button from the Chemistries Menu fig 7 3 1 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 1 Types Selection Use the F4 and F5 buttons to go to the next previous option The keys from 1 to 9 of the keyboard select directly the correspondent option In fig 7 3 3 in the Type field is possible to change the name of the method max 15 characters and the code number max 3 characters place the cursor in the field and press two time the button The available types are End point e Bichromatic Kinetics e Fixed time Differential Differential with blank reagent Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifW
78. le to set a profile for the selected patients On the lower part of the screen will appear the work list program bar see fig 7 4 3 with 63 positions The symbols on it have the following meanings P 1 one patient for a test s list e R 1 patient for a test s list and the previously memorized results e C depending on the selected test a control can be executed in this position S depending on the selected test a standard can be executed in this position dot Indicates a free position Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 4 2 Load Work List Pressing the F2 button in fig 7 4 1 the software allows to load a work list from an external PC through the serial port RS232 NOTE This option is valid only if an external PC is connected If the existing work list of the ECHO is not empty the ECHO will ask 1f you want to erase the previous patients Will be showed three options type e 0 to stop the working list loading and to save the previous work list e 1 to load only the tests work list e 2 to load the patients and the work list of the test At the end of a correct loading the following screen will appear fig 7 7 6 to confirm that the operation is successfully completed Clear previous patients 0 No 1 Clear only tests 2 Clear all Work list loading Disk re
79. n of the Curve This parameter appears only when the number of standards is greater than 1 This multiple parameter permits the visualization of the values curve the upper line is the Y coordinate O D the inferior line is the X coordinate Val Std The curve has as many points as many number of standards has been defined in the parameter 11 The result is calculated with the Cubic spline interpolation Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 EDIT METHODS Method n 2 Type Bichromatic IgA Filters s 340 nm 700 nm Code IGA Sample volume ul 10 Reagent 1 Volume uL 500 Reagent 2 Volume uL 0 Reag 3 Volume ul 0 Number of washes Stabilization time s Reading Time s 5 Cycle 24 R1 Incubation time s Position of reagent 2 Number of standards 5 Number of controls 1 Position of standard 1 Position of Control 9 Interpolation Cubic spline Curve O D 0664 2403 4283 7009 9829 Val standard 5 800 16 30 98 00 192 0 389 0 Dilution Ratio in Rep 6000 Sample dilution 1 Linearity 200 0 N of decimals 4 R Blank value min 0000 max 2000 Normal Value min 60 00 max 360 0 mg dl gt Blanks are used in calculation Type of test gt The calibration is KEPT in memory 1 Endpoint 3 Kinetic 4 Fixed Time 5 Differential 6 Diff Sample bl SELECT METHODS
80. nce solution with a manual pipettor It is necessary to prepare four samples using the automatic samples dilution function and four samples with no dilution programmed but already diluted with a manual pipettor first program Fl WORKLIST F1 INSER WORK LIST then execute F2 EXECUTION F3 AUTOMATIC SAMPLES DILUTION The 4 4 solutions are read as the previous test 2 photometer accuracy test ODp optical densities with automatic pipetting ODr optical densities with manual reference pipetting ODpm D10Dp An ODrm gt ODr on Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 6 4 The two values obtained with the instrument in O D TEST FS SERVICE F3 DIAGNOSTICS F2 are compared The difference between the two values must be lower than 4 ODpm ODrm ODrm 100 lt 2 Carry Over This test aims to verify the contamination between a highly concentrated sample and three following null concentrated samples The test is performed using the Potassium Bichromate solution with an O D of 2 000 mAbs at 340 nm wavelength in sample position 1 and three tubes of distilled water in sample positions 2 3 and 4 It is necessary to prepare a special test method type end point sample volume 250 ul reagent volume 250 ul e reagent position 1 incubation time 0 sec Runni
81. ng the four tests it is requested that the O D of the first blank sample is lower than 20 mAbs 1 of the concentrated solution In case of failure the O D of the two following water samples gives an index of the carry over progression over several samples Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 OPERATING PROCEDURES Tel 7 1 1 7 1 1 1 Preparation Prior Operations In the following paragraph are quoted the necessary information that the user must know for a correct use of the instrument The information about sample handling reagents and disposable materials are general it is recommended to read the respective Manufacturer guides Safety Recommendations and Remarks Read carefully the Safety section for detailed safety instructions To reduce risks it is important to follow the safety precautions listed in Section 2 The Instrument Calibration the Setting and the Adjustments of the instrument should be carried out by Technical Support Personnel only User Skill Level User appointed for instrument operations must have a good technical skill in medical In Vitro Diagnostic IVD analysis as highlighted in the Safety section the use of Good Laboratory Practice is mandatory to get the proper level of safety when the instrument is used for medical in vitro diagnostic use It
82. nnections Verify the washing solution The syringe has difficulties in Verify the valve fillin and a emptying Control the piston losses blocks Execute a washing of the tubes Disconnect and clean the syringe The sampling probe is dirty Control the washing solution Change the needle cleaning filter Air bubble in the syringe Not repetitive analysis The flow cell is dirty The reaction segments re used mono use Peristaltic pump tube consumed change periodically Check the aspiration tube Non constant aspiration in the Check the peristaltic pump tube flow cell Control the flow cell probe mechanism Tube broken or not correctly connected Air bubble in the flow cell Loss in the flow cell control the flow cell holder Flow cell empty Bubbles in the flow cell Auto zero error Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 Controls out of range Aspiration arm going down without aspirating The instrument is not executing its initialisation The internal printer is not functioning Losses in the connection tubes Dirty washing solution Halogen lamp expired Halogen lamp burned Peristaltic pump tube Compare the method with the control values Respect the correct working conditions and control the method
83. ns The original packing can be re used 1f the instrument has to be moved or sent back Transport Damages Check Check the package carefully for damages The eventual damages caused by the transport should be contested immediately to the shipping company and noted on the delivery note Once the goods are delivered to the shipping company the responsibility for its integrity is his until the delivery of the goods If you find some anomalies 1 Do not refuse the shipment 2 On the receipt of delivery write a note on the fact 3 Do not remove the package Leave the instrument in the original package and request immediate inspection from carrier within 15 days from delivery if the delivery is international the inspection must be requested within 3 days from delivery NOTE Check if the above procedure is in conformity with local regulations and or special agreements with the shipper Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 3 4 3 Removal from Package Open the boxes and extract the instrument carefully Verify that all the parts described in the delivery note are present including the welcome kit as well Control the serial number of the instrument if the same corresponds to the one indicated in the delivery note Remove the lid and then remove the two lateral elements that secure th
84. oad is strongly recommended Instrument Installation Procedure Connect all the cables included the monitor and the printer ones if you want use an external printer A description of the cabling is outlined in the table shown below FUNCTION CABLE Power line Three pole Bulgin F Input for printer Centronics Output for monitor 25 pole M 37 AMP M Power line monitor Three pole Bulgin M Input for keyboard Multipole shielded Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 3 5 3 3 5 4 3 5 4 1 Fuses Four external protection fuses are inserted into the switch assembly 3 15A Accessories The ECHO accessories are indispensable parts for the instrument working the instrument needs for its operation to be connected with two external tanks one contains the liquid for the hydraulics filling and the other is used to contain the waste liquids The connection between tanks and instrument is described on the next section Tanks To install the waste tank insert the waste tube coming from the peristaltic pump positioned on the right side of the instrument fig 3 2 into the 1000 ml waste bottle furnished with the instrument fig 3 2 Position the bottle of 500 ml containing the washing solution our code E LV01 on its seat on the right of the diluter module in
85. of distilled water while for the others 1t uses 500 micro liters Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 3 1 28 Blank Reagent Selection Is possible to choose between two options see fig 7 3 7 1 NOT USED in calculations 2 be USED in calculations EDIT METHODS Methodsn 1 gt gt Type Endpoint GLUCOSE Filte rxs 505 nnm Code GLU Sample Volume uL Reag 1 Volume uL Reag 2 Volume uL Reag 3 Volume uL Number of Washes Stabilization Time s Reading Time s 3 Cycle 12 R1 Incubation Time s Position of reagent Number of standards Number of controls 1 Position of standard Positionof Control 16 Standard value 100 0 Reagent b lank usage Factor 0000 1 NOT USED mcaks 2 be USED incaks Dilution Ratio in Rep 6000 Sample dilution 0 Linearity 600 00 N of decimals 4 R Blank Y alue rain 0000 max 1000 Normal Value min 65 00 max 110 0 mg dl gt Blanks are used in calculations gt The factors is KEPT in memory SELECTMETHOLS NEXTMETHOD PREY METHOD SELECT OPTION NEXTOPTION fig 7 3 7 In fact during the calculations ECHO can compare or not compare the optical density of the blank reagent with the optical density of the sample In any case a test with the blank reagent will be executed to check the reagent quality Typically the end
86. or physiological solution and press a key ECHO will proceed with the dilution Automatic standard dilution From the Main Menu press F2 Execution and F4 Automatic standard dilution in case you want to read for the first time a curve or you want to re read it to reconfirm the calibration factors For ex In case of a calibration curve with 5 standards put in standard position 5 on the sample plate a serum cups full of concentrated standard Put in reagent position 27 a reagent bottle with distilled water and press a key Note The above two procedures are suggested on the video Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 6 Results Handling At the end of the normal cycle execution the ECHO will inform you by 3 signals and if there are other memorised tests to execute it will return to the Execution Menu on the contrary will be showed the Main menu fig 7 2 1 To read the tests results press the F3 button in the Main menu the following screen will appear fig 7 6 1 Le PLAY RESILTS FRINTRESILTS SEHD REL REFETITIOHE CONTROLS fig 7 6 1 The five buttons showed on the bottom of the screen have the following functions Press this button to visualize the results per patient or DISPLAY RESULTS per test i p F2 PRINT RESULTS To print the results by group of patients F
87. otassium 02 Urea 06 6 P T 10 Triglycerides 14 Lypase 15 Tron 19 Gamma G T 21 Choliresterase 23 Sodium 25 Magnesium 25 Alburune 27 HDL Chol 31 Alfa HBDH fig 7 3 2 O4 Calcium 03 Alkaline Phos 12 Unie Acid 16 Acid Phos 20 CEK WAC 32 User Test Now select a method typing its code from 01 to 32 ex 02 to select Urea will be showed the following window with all the selected test parameters fig 7 3 3 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 EDIT METHODS Method n 2 Type Fixed time UREA Filters s 340 nm Code BUN Sample volume ul 5 Reagent 1 Volume uL 500 Reagent 2 Volume uL 0 Reag 3 Volume ul 0 Number of washes 2 Stabilization time s 13 Reading Time s 17 Cycle 36 R1 Incubation time s 72 Position of reagent 2 Number of standards 1 Number of controls 1 Position of standard 2 Position of Control 16 Standard value 50 00 Factor 633 1 Susbstrate depletion 7000 Dilution Ratio in Rep 6000 Sample dilution 0 Linearity 200 0 N of decimals 4 R Blank value min 8000 max 1 800 Normal Value min 15 00 max 50 00 mg dl gt Blanks are NOT used in calculation gt The factor is KEPT in memory Type of test 2 Bichromatic 3 Kinetic 4 Fixed time 5 Differential 6 D samp
88. perations ia 1 3 3 Maintenant Ens A A A Bei ele deeded obec 1 3 4 Transport AA A O osc aeatenevs Risks Related to the Use cia tidad eos N A aa I amp I H man A A a as 14 2 WP ersonalSatety AS O noe 1 4 3 Information on Infectious Liquids and Parts ooonnonnnccnnncninccnoncconnninnnonnnonnno A O II A tua tahsite sdcleants LESZ A ocd di tat acultngd delete neat it Saba setrga tt as Je SS Contamination deses e sese eea E E a a E tenets lowes Recommendations for Optimal Performance oococonincnoconononcnnoncnnnconanononnncnncnnnanns Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it NY A 4 A W N VD 0 0 N NI ND DNA A hh HL RA Q El1121A Echo PC User manual Rel 1 1 Section 2 SYMBOLS 2 1 List of Used Symbols and Physical Position Overview oooooocnoccconcconncconcconcnonnss pag Section 3 INSTALLATION A a a RERE E taconite pag ZIET Supplied Materials e o te df o pag Sl Standard Supply tri deta pag ZEL MO PODIO DA AA idee E nti pag 3 2 Installation Constrains s seeseseseesseseeeseessessessessesstestsseestsstesseeseesresseesresersseesse pag ESA A A a pag 3 2 2 1 PWAROM ACTA i ee acs pag O Sarde Gerda eet iva ie ae Sade pag 3 3 Stora o a E R pag 34 Unpacking osien ia hoe n a ER E E EA EE A o pag 34 1 Package Characteristics neinei ua o kerrin A as pag 3 4 2 Transport Damages Check erszsssndscsstazahec
89. procedures can be modified added or deleted in easy way The software is protected by passwords that only authorized personnel can modify How to Start After the initialization procedure the ECHO will ask for an analyst ID number 0 4 Analyst 0 has full access to the system while analysts 1 to 4 have restricted access to Edit Methods Read mode only e Edit Profiles Read mode only e Load Dump methods No access Copy Swap methods No access Edit Parameters No access e Laboratory Data gt No access After the analyst number the ECHO will ask for a password It can be alpha numeric and can have up to 6 characters If no password is stored ECHO will ask to insert a new password Insert new The standard password memorized as default is 000000 6 times 0 Access to the instrument is denied until a valid password is typed The master analyst 0 can access to the Laboratory Data where are recorded two lines for the Laboratory Header printing and the five Analyst names Blanking an analyst name will disable that analyst and clear the related password Analyst 0 cannot know the password of the other analysts but can only cancel them With the ECHO numeric keyboard the analyst name can be canceled with the CLEAR FEED key Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual
90. processes the following basic operations Reagent distribution process Incubation control Photometric reading process Data analysis evaluation process Analysis results printout process All the above mentioned tasks can be fully automated and software controlled reducing time and human resources and assuring a final quality level result free from accidental errors due to the human routine action tolerance Each task is executed using both electromechanical devices such as stepper motors pumps valves etc and electronics part such as active and passive components micro controller and microprocessors and so on including software programs The ECHO also includes an electronic photometer working on 340 700nm range that represents the basic instrument for the automatic reading of the analysis results and for controls evaluation Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 WARNING All working procedures must be validated on the analyser before carrying out every laboratory routine These procedures are normally validated by the distributor if the required data are not available for any particular assay the user must validate these procedures himself Any modification to pre validated routine must be validated again The main topics of the ECHO instrument are the following
91. r manual Rel 1 1 3 INSTALLATION 3 1 Equipment Overview The ECHO is provided with internal LCD screen that allows to control all its functions and operation Its working area is planned to work in safety and with maximum productivity 1t enclose the reagent plate where are placed the reagent tubes the sample plate that contains the sample vials ant the incubation plate Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 3 1 1 Supplied Materials In the following sections are listed the supplied materials subdivided in a standard supply list and in a list of options 3 1 1 1 Standard Supply List EDIF CODE OLD CODE 1 El0703CV1 P10 0000 0023 Halogen lamp MATE N LOCK connector 1 El 0801B P10 0000 0008 Tubes kit 1 El 0802A P10 0000 0010 Sampling and Aspiration Needles kit 1 ElO710A P10 1000 0001 Reagent bottles 25 ml 27 pos pack 30 pcs 1 ElO711A P10 1000 0002 Reagent bottle caps 25 ml 27pos pack 30 pcs 1 El0714A P10 0000 0003 Needle cleaning filters pack 1 ElO715A P10 0000 0004 Reaction segments pack 100 pcs 1 ElO716A P10 0000 0005 Serum cups pack 1000 pcs 1 El0717A P10 0000 0006 Thermal paper pack 3 pcs 1 El 0702B P10 0000 0012 Fuses kit 230V 1 El0721A P10 0000 0017 Water charge bottle 1 El 0722A P10 0000 0018 Waste bott
92. r of other different applications The use of the instrument for some of the mentioned application e g blood screening may require in same countries the approval or registration from Government Agencies Instrument Functions Overview The ECHO is a fully automated open system that can process most Clinical Chemistry tests All operations are automatic and programmable e Manual patient sample entry e Reagent distribution e Incubation from room temperature to 42 C in the incubation plate Washing Reading e Data analysis and printout Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 The ECHO has the following important features HARDWARE ECHO has the following features It is an open system that will not restrict the customer to anyone reagent supplier Carry over between samples is eliminated tanks to an optimized washing procedure It has a photometric station allowing precise and rapid reading of absorbance for each test SOFTWARE The software is an easy to use management system with an interactive communication between the operator and the system The use of this type of software simply to use allows the operator to perform precision testing with minimal computer training Additional features of the software include Easy access to menus e Easy step by
93. s a substance with homogeneous concentration respects this law through its path inside the solution the law is expressed by the following formula I ee where Io Shooting wave amplitude I Transmitted wave amplitude K A Spreading constant of substance wavelength function d Wave optical path inside solution C Substance concentration in solution Through use of specific reagents in solution for the substance we want to measure it s possible to overvalue the spreading constant for a fixed wavelength so transmitted wave amplitude becomes concentration function EELA gt Ex ES I Kd I This relation allows evaluation of substance concentration by measuring of Absorbance ABS m2 kdC Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 The measure chain could be represented by the following scheme fig 4 1 0 a R i OLEE gt Da rn eceiver Selective filter Amplification and focal system pr Y Analogic Section Digital Section fig 4 1 5 4 Management System The ECHO software operates under DOS operative system A series of menus enables the user to navigate within the programs The ECHO software has a list of assay methods pre programmed by a Technical Support Representative This protocol list can be easily modified deleted or even added to usin
94. separated by a dot identify the profiles that will be executed for all the patients for fast programming only From this screen pressing the F2 and F5 buttons is possible to display the tests list and the profiles list Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 Pressing the F1 button the following screen will be displayed fig 7 4 4 EDIT SAMPLES Sample Number Sample ID code Urgent UNZ 09 Cholesterol 10 Triglycerides 11 Creatinine 13 Tot Protei 14 Lypase 15 Iron 17 Potassium 18 Amylas 19 Gamma G T 21 Choliresterase 22 Phosphorous 23 Sodium 25 Magnesium 26 C K MB 27 H D L Chol 29 Toumine 30 Phospholipides 31 Alfa HBDH 32 User Test di oto ol ne eee ras S3555 5 5 PREV SMPL SELECTTEST SELECT PROFILE fig 7 4 4 This screen allows to associate to a specific patient the test or the profile that we want execute On the upper part of the screen there are the patient data on the lower part there are the tests To recall an existent patient press F1 button Se ect Patient and type the correspondent number An other way is by pressing F2 button to go to the Next Patient or F3 button to go to the Previous Patient A patient is identified by the following data Sample ID code an ID of 13 alphanumeric characters Urgent 0 NZ 0 corre
95. seteccecececsseecsdaccessnsesscesetesseccoandvenss Management ys Mic toi 5 4 1 Software Architecture occccccncncnonononononononononnnnonnnnnnnnonononononononononeneneneneneness ALT Mala Mem AR 5412 O aaa es 54 ld EX CCULIOM ae ate a O SALA RESUS pride ass SANS CSS id pi A A o teedoa a out atte Section 6 PERFORMANCE CRITERIA AND LIMITATIONS General Tate Mty ic PROTONES EA A a a a Teste Ello PEO ii ae RT EE RER E EEE EE AEE RN A ES 6 2 3 A ts e NA A en meadaaent cast ETS 631 PRECISION A it id eels es Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it wo no N N N NN A A Mu Bb A N A U a A W Q e e ee Rh Ro OO a A O O El1121A Echo PC User manual Rel 1 1 O A A A II lida ease deck asics de csbu al S 6A CUTY OVT acai eat seats A A tate EA Section 7 OPERATING PROCEDURES 7 1 Preparation Prior Operations uscar iii 7 1 1 Safety Recommendations and Remarks o ooonnconincnincnnoccconnconnconnnconccconocnnno 7 1 1 1 User Skill Level A tit TAZ AA A 7 1 2 1 Instrument Built in On Line TeSt oooonnnnnononononononananananononononononononononons Tl 3 Sample Ha dliNg ansien eed Paes tal aa Meal seattle Melanin oad Seed Joel 7 1 3 1 7 1 3 2 7 1 3 3 7 1 3 4 7 1 3 5 Simple PI dee O a s A a Ear Oey are e e Bor nao E Preservation eiiie A A A es aS Sample Minimum VOM ee Acetate en
96. sinfection Procedure ocoocociccnoconoconoconnconnconanononononnninncnns SL Metalic Needle en aa tea a a a e a 8 1 3 3 Waste O ial cece eons avd is LA Waste Tank A a Seanty Seances Wass 8 2 User Maintenance Warnings viii dida dianas deis 8 3 User Daily Maintenance POC dE ii 8 4 User Weekly Maintenance Procedure ici in Section 9 TROUBLESHOOTING Ol Normal Operation Basics ista stas OD Diagnostic System nieo a cds 9 3 Trouble Sources Classification RemarkKkS oooonnccnnnnninnnnococonncnoncnoncconncconacnnnnonnss Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it NH UU BW q W NNN El1121A Echo PC User manual Rel 1 1 9 4 9 5 9 6 Correct Operations Messages de a Error Messages List and User Required Actions oooooooccnnoccnoccconaconcnonnncnnnccnonons COTTA AEE a EE E E A E ETES E EEE E Section 10 TECHNICAL SPECIFICATIONS 10 1 Instrument Technical SpecificatiON oooonocnincccnonoconononnconncnonoconn cono cono nocnocnnc conos OTL AE a e n a a net eR eRe 10 1 2 Sera and Reagent Pipetting Station ooooonnncninnnnonnconnnonnnconncconocnncconnncnnncnno 10 1 3 incubating Statens a diia 10 1 4 Ph tomettie RA e Lael 10 2 Adjustments and SEM tsa aieas esd ase aanunen Maen 103 Electrical Re quirenisiits RIA AA RA 10 4 Operating Environmental Requirement oooocccnnccconococnconncconoconcconn nono ncconocnnncnnnos 10
97. spond to not urgent 1 corresponds to urgent Dil 0 corresponds to the pre dilution percentage Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 To create or modify the data of a patient select 1t and press the F6 button the following screen will appear fig 7 4 5 Sample Number 1 Patient ID code Pirandello Urgent ONZ 0 Pirandello Luigi 3 01 01 01 Sex M Via delle Driadi Roma Italy CONAN NEXTSAMPLE PREV SAMPLE SELECT A TEST SELECT PROFILE fig 7 4 5 From here you can modify all the data that describe a patient Once you have selected the patient you have to set the tests for that patient refer to fig 7 7 3 Use the cursor buttons to move though the columns and in particular A Move up y Move down lt lt Move left Enter Move right Select a test placing on it and pressing the F4 button Another way to select a test is typing its numbers from 1 to 32 on the keyboard to cancel the selection type again the test number Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 The Del button allows to delete all the selected tests the Esc or the Page Up buttons allow to return to the previous menu With the F5 button is possib
98. t for only one patient with the possibility of an auto dilution Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 6 3 1 Repetition of One Test for all patients Pressing the F1 button in fig 7 6 5 will be showed the following screen fig 7 6 6 REPEAT ONE TEST Code of the test to repeat Dl Ghucose 02 BUN FT 05 G OT 06 G P T 09 Cholesterol 10 Triglycerid es 13 Tot Protein 14 Chlorides sampled 17 Abumin 18 4 Amylase 19 Gamma G T 21 Cholinesterase 22 Inorg Phos 23 Phos pholipids 25 Magnesmm 26 C K M B 29 Carbonate 30 Blood Sugar Li 32 U ser Test Now type the code of the test to repeat and press the F1 button to activate the test repetition for all the programmed patients The activated tests are marked in bold Repeat this operation for all the tests to repeat and then press Pg Up BackMenu button Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 7 6 3 2 Repetition of One Patient Pressing the F2 button in fig 7 6 5 will be showed the following screen fig 7 6 7 REPEAT SINGLE SAMPLE Sample number Code of the test to repeat Autodilution 1 Yes 0 No 01 Ghicose 02 BUN FT 0G Tot Bilirubin 80 00 05 G OT 06 G P T
99. troduce the tube coming from the diluter valve into the bottle Make sure that the tube of the peristaltic pump is inserted and the rotor is well tight Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edif edif it El1121A Echo PC User manual Rel 1 1 3 6 Software Installation The ECHO software is installed and configured by specialized personnel to assure an optimal working of the analysis system 3 6 1 Requirements and Recommendations The ECHO software is optimized to work with this instrument and it uses in the best way its potentialities Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 4 THEORY of OPERATION 4 1 Abstract ECHO is an automatic multi parameter analyzer for Clinical Chemistry developed for medium or small size labs This equipment allows to work in batch mode or in Urgency procedure reaching its maximum productivity 180 tests hour with the optimized batch procedure The ECHO can store 64 methods located in two different panels and each method can use until 3 different reagents It is possible to set 16 different profiles from these methods The instrument performs the test repetitions and dilutions automatically or according to the operator choices The Instrument can perform with automatic
100. ts s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 13 International and European Norms Compliance This document was written according to UNI EN 591 1996 standard The ECHO equipment meets the following directives EN 55001 EN 61326 1 Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 1 4 Patents Currently there are not patents for this instrument Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 15 Document Intended Purpose This document represents the User s Manual of the ECHO automatic multi parameter analyzer It is forwarded to laboratory technical personnel that have experience in laboratory practice and in laboratory automated equipments handling NOTE The Manufacturer declares that the information inside this manual have to be considered sufficient to perform a proper use of the referred equipment only in case of readers who have previously followed a manufacturer s specific training course Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual
101. ts that all products of its manufacture the Product or Products shall be free from defects in material and workmanship and is conform to Edif Instruments S r l standard specifications for such equipment This warranty is subject to the equipment being used operated handled and maintained by the Buyer under normal conditions in accordance with good operating practices and in compliance with any written instructions furnished to the Buyer by Edif Instruments S r l and is void as to any equipment modified altered or damaged by persons other than Edif Instruments S r l Failures which are necessitated by inadequate or incorrect maintenance of the instrument by the customer including accident abuse misuse or neglect fare theft water or any other cause other than instrument failure will violate the warranty The above described warranty valid for one year from the installation is on ex works Rome Italy basis and the consumable parts such as tubes syringes lamps flow cells etc are excluded from the warranty Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY 2 Tel 39 065127161 Fax 39 065127550 Web www edif it email edif edif it El1122A Echo PC Maintenance manual Rel 1 1 11 3 Spare Parts ans Consumables ECHO PC ACCESSORY BOX EDI F CODE OLD CODE
102. ution as much as possible When a method has done all the samplings the memorized number of washings will be done At the beginning of each cycle an auto zero procedure is executed e A washing procedure is executed at the beginning and at the end of each cycle For the Urgent mode F2 button the ECHO work according the following principles e Only the patients signed as Urgent will be taken in consideration The ECHO will execute one patient for time for all the methods with a maximum of 27 reagents At the end of a patient working the instrument will sing with 3 bips the operator can verify the reagents and the sampling and can start a new test procedure e The principles are the same as the ones described in the Batch mode For the successive patients the initial washings and the auto zero procedure are not effected e The blank reagent is executed only for the first patient on whom the method was programmed Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 7 5 1 Batch To run the Batch mode press F1 button in fig 7 5 1 Next screen will be showed fig CES DIA y TESTS AND CONTROLS TO RUN TESTS to run 2016 09 Cholesterol ine 12 Uric Acid 2016 a 16 Ad Pie 2016 17 Potassium gt E 20 C K NAC 21 Cholines Erase Sodi 24 LD H P 25 M resum CE i H D L
103. xt cycle until the execution of all the programmed test During the cycle the end point methods including the bi chromatic ones are distributed for first and will be measured at the end of the incubation time During this interval the Fixed Time methods kinetics and differentials are executed The ECHO will begin the sampling of the tests of one method waiting the incubation time When the incubation is terminated the instrument continues alternatively with a reading of the incubated sample and doing a new sampling If the cycle is composed only by End Point methods the same operational mode is used to increase the execution as much as possible When a method has done all the samplings the memorized number of washings will be done At the beginning of each cycle an auto zero procedure is executed A washing is executed at the beginning and at the end of each cycle Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 For the Urgent Patients the ECHO is working according to the following principles Only the patients signed as Urgent will be taken in consideration The ECHO will execute one patient at a time for all the methods with a maximum of 27 reagents At the end of a patient the instrument will sing with 3 bips the operator can verify the reagents and the sampling and can initiate a new execution
104. ypochloride has a concentration at 5 25 if so prepare the solutions as follows Solution A approx 1 200 ml of hypochloride and 800ml of deionised water Solution B approx 0 5 100 ml of hypochloride and 1000ml of deionised water Instrument Disinfection Procedure First moisten those surfaces where you can see traces or incrustations of contaminated liquids with cotton wool soaked in solution A Successively remove the incrustations and moisten the above areas again with the same solution Those parts must remain moistened for at least 15 minutes to obtain a good level of disinfection When finished remove the hypochloride with cotton wool in deionised water Metallic Needles Carefully unscrew the two needles and soak them in a container with solution A for 15 20 minutes and then carefully rinse them with deionised water Edif Instruments s r l Via Ardeatina 132 00179 Roma ITALY Tel 39 065127161 Fax 39 065127550 email edifWedif it El1121A Echo PC User manual Rel 1 1 8 1 3 3 8 1 3 4 8 2 8 3 Waste Tube External Discard the waste tube in the waste container for contaminated materials Replace it with a new one Alternatively if the tube is not deteriorated you may leave 1t soaking for 20 minutes in solution A afterwards rinse the tube well with tap water Waste Tank Empty the waste container completely Fill the tank with solution A and leave it soaking for about 20 minut

USER'S MANUAL - Frank's Hospital Workshop

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