LENA SERVICE A5 _rev 3_enric 04-2003
Contents
1. ESP Spanish Every time than we press 1 key the selection changes to the next one P means the type of online selection Then L it s Linear to work with Linear Thermic Printer P it s Printer to work with M180 Seiko printer or DPU414 without graphics and O it s no printer disable all the printout Every time than we press 2 key the selection changes to the next one 77 LENA Version 03 04 2003 G means automatic printout of the partial graph Then G enables the automatic printout of the partial graph a space means without automatic printout of the partial graph Every time than we press 3 key the selection changes to the next one T means automatic temperature conversion of the results Then T means automatic temperature conversion of the results And a space means without automatic temperature conversion of the results Every time than we press 4 key the selection changes to the next one To setup that parameter the motor must be stopped without any analysis in work C means printout of the record sample in large mode That means the information of one sample it s printed in 5 lines to be clearer Then a enables the normal printout of the record sample A printout of the records sample in large mode Every time than we press 5 key the selection changes to the next one 30 mean automatic printo2. 27 LENA Version 03 04 2003 28 LENA Version 03 04 2003 The LENA allows tests to be conducted in two different operating modes 1 HOUR OPERATION MODE 24 minutes 1 HOUR 2 HOURS OPERATION MODE 48 minutes The Instrument is delivered shaped with the 1H cycle If we change the type of analysis cycle the working memory prior to this modification will not be deleted To change the cycle switch off the Instrument and reset it while pressing the key 1 until one of the two messages of the corresponding cycle change is displayed or Then the change must be done 29 LENA Version 03 04 2003 30 LENA Version 03 04 2003 31 LENA Version 03 04 2003 32 LENA Version 03 04 2003 SECTION 3 OPERATION This section describes the system starting procedures 3 1 SWITCHING ON THE UNIT 3 2 GENERAL 3 3 STATUS DISPLAYS 3 4 FUNCTIONS 3 5 SKS SAFE KEEPING SYSTEM 3 6 KINETICS CONTROL 3 7 HOW WORK 33 LENA Version 03 04 2003 34 LENA Version 03 04 2003 3 1 SWITCHING ON THE UNIT Switch on the unit using the switch located on the rear left side of the Equipment The following message will be displayed around 2 minutes and it will check its different electronic and mechanical components To change the cycle type of the Instrument reset the Unit while pressing the 1 key If a day change has occurred the data memory will be cleared and the working list sequence will begin from the first position The
3. RESULT 1H RESULT 2H IDENTIFICATION CODE 40 LENA Version 03 04 2003 If you do not wish to enter a result to a specific sample simply press IN without entering any number to go to the next sample If you make a mistake when entering a digit press ESC DEL for the cursor to return to the beginning of the record and then re enter the correct result To exist this function press ESC DEL to return to the main display NOTE Any result being modified by the user will be indicated with an asterisk before it 3 PRINT RESULTS only in case of LINEAR or PRINTER online mode Works in the same way of SEND ONLINE see page 43 4 REPETITION OF A SAMPLE This function is used to repeat a sample in the same position and with the same sequence and ID numbers In this way the arrangement on the working list or the sequence number is maintained To make it correctly take out the tube shake it enter this function select its position and afterwards enter it in this position Press 4 at the main display and the display show onfirm choice by pressing IN otherwise press ESC DEL to return to the main display If you If you wish to enter the menu c have confirmed by pressing IN the display will show Enter the position number of the sample you wish to repeat If the position number has two digits it will not be necessary to press IN since the Instrument will automatically accept the p
4. checkings being completed 2 minutes approx the main menu message will be displayed The Instrument is now ready to begin an analysis cycle 3 2 GENERAL Tubes must be correctly levelled with the blood sample according to the level marking on the tube The tolerance of the Equipment with regard to the level is 5mm and 11mm Otherwise the Instrument will display an L E level error message 35 LENA Version 03 04 2003 The sample should be shaken by slowly inverting the tube during approximately 5 minutes before inserting it in the Instrument 5 MIN It is not necessary but advisable to identify the sample to begin the test The test starts when the tube is inserted in the Instrument Work should be performed consecutively Begin daily job at position 1 and so forth until reaching position 16 When reaching position 16 and if there are still samples to analyse start again from position 1 sequentially numbered 17 and so on If an analytical cycle is completed and more tubes arrive continue from the position following the last used one In this way the work list will be adequately arranged When every tube has been identified the identification menu will display the next position to be used unless otherwise instructed Do not remove the tube from its position until the test is completed If you do so the test will be aborted and the S E message will appear on the results printout After 24 or 48 min
5. minutes This period elapsed the reading plate will automatically be switched to a safety position allowing you to turn off the Equipment and subsequently transport it with no problem 15 LENA Version 03 04 2003 16 LENA Version 03 04 2003 1 4 INSTALLATION Place the Instrument in its final location Make sure the mains cable is properly connected to the power receptacle of the Instrument 2 and that the mains tension is between 100 and 240V Start the Instrument using the power switch 1 located on the left rear part of the Device The Instrument will check the mechanism for an approximate period of 2 minutes and immediately after the main menu will be displayed 17 LENA Version 03 04 2003 18 LENA Version 03 04 2003 19 LENA Version 03 04 2003 20 LENA Version 03 04 2003 SECTION 2 DESCRIPTION 2 1 INSTRUMENT DESCRIPTION 2 2 CONTROL PANEL 2 2 1 DISPLAY 1 2 2 2 KEYBOARD 2 2 3 WORKING PLANE 3 2 4 REAR CONNECTIONS PANEL 2 5 CHANGE WORKING CYCLE MODE 1H OR 1H 2H 21 LENA Version 03 04 2003 22 LENA Version 03 04 2003 2 1 INSTRUMENT DESCRIPTION The LENA has been designed to operate without needing an adapter with either open or vacuum tubes containing a sodium citrate solution as anticoagulant The capacity of the working plane is 16 positions divided into 2 rows each with 8 positions The duration of the test cycle for every sample depends on the selected operation mode in I hour mode the total
6. test time is 24 minutes while in 1 2 hour mode the time is 48 minutes In both cases results are expressed in Westergren millimeters System throughput is 40 samples per hour The basis of the system allows the random access of samples so that the analytic cycle of every one begins once each tube is inserted Therefore it is not necessary to fill the 16 working positions to start an analytic cycle When the test time for a sample is completed the corresponding message will appear on the display and we will be able to consult it through the display or send it to a peripheral unit informatic system or printer through on line connection The Instrument allows the user to enter the samples I D codes using either the keyboard or a bar code reader 23 LENA Version 03 04 2003 2 2 CONTROL PANEL Located under the working plane it consists of display and keyboard 2 2 1 Display The LENA is equipped with a backlight LCD with 24 characters x 2 lines The status of every position is displayed 2 2 2 Keyboard The Instrument features a keyboard with 10 numeric keys that are also function keys When the READY prompt is displayed every key provides access to a specific function These keys enter number values only when the Instrument requires them otherwise they are function keys 24 LENA Version 03 04 2003 In addition the keyboard contains the following keys In It confirms the access to a function or the numer
7. the main screen press Esc Del for some seconds 79 LENA Version 03 04 2003 6 3 OPEN THE INSTRUMENT To open the instrument proceed as follows a Disconnect the Instrument from the power supply and pull out the connector cable of the Instrument b Remove the 5 screws on the bottom part of the instrument c Place that cover in front of the instrument Make attention at cable position when you open and close the instrument I R cable it s has a long ring in the front of instrument LCD cable must be placed out of the range of I R movements 80 LENA Version 03 04 2003 6 4 ELECTRONIC PARTS LENA SCHEMATICS IR BOARD MECHANIC SENSORS in Pt Two boards compose the instrument The Infrared Board and the main board The main board are placed in front of the instrument and controls all the functions of the instrument Power Supply Filter The step motor The LCD display The I R Board reader and mechanic sensors The serial port The keyboard Calculation functions 81 LENA Version 03 04 2003 The performance of the power supply are Main voltage input 100V to 240V AC and output 5V CC Frequency 47 63 Hz Current 2 A Energy consumption 10 W Before the power supply we find the socket and switch It s placed in the backside of the instrument The Step motor it s driving trough a chip in Main Board MC3479P The LCD Display and the Keyboard are driving trough the Main Board The
8. to transmits to the LINEAR THERMIC PRINTER the results In that mode the results will be automatically printout at the end of analysis and enable the menu 3 that works in the same way of menu 6 but only to transmit to the printer e The ON LINE O mode suitable to transmits to a computer system either to the central computer of the laboratory or to a personal computer e The PRINTER P mode suitable to transmit to a Seiko M180 printer or DPU414 without graphics In that mode the results will be automatically printout at the end of analysis and enable the menu 3 that works in the same way of menu 6 but only to transmit to the printer To select or visualize the transmission mode see Section 6 2 To input identification codes by means of the bar code reader we have to make the same operations as in the manual input but reading the code with the reader 65 LENA Version 03 04 2003 5 2 FEATURES One way connection with a remote computer system DATA OUTPUT VIA RS232 9CTS FEMALE CONNECTOR 5 NOTE For a correct functioning of the linkage and the Equipment it is very important that only these 2 pins are connected to the shortest coupling wire INSTRUMENT PINS TX PIN 3 transmission GND PIN 5 ground PROPERTIES BAUD RATE 9600 DATA BITS 8 PARITY NONE STOP BIT 1 WITHOUT FLUX CONTROL 66 LENA Version 03 04 2003 5 3 DATA PACKAGE CONTENTS ON LINE ONL MODE The following is transmi
9. 1H and 2H results POSITION NUMBER SEQUENCE NUMBER RESULT 1H RESULT 2H IDENTIFICATION CODE OVERFLOW KINETIC FLAG In this way the Instrument indicates that the sample has an unstable performance and it is advisable to visually check the result or repeat the test 51 LENA Version 03 04 2003 3 6 KINETICS CONTROL The Instrument is equipped with a kinetics control system allowing to check the linearity of the tests being made When the equipment leaves the Factory the kinetics control system is deactivated If the kinetics control system is activated Section 6 2 explains how to activate it and how to check if it has been activated the Instrument checks that between two successive readings approx 2 minutes the red blood cells fallout is not higher than 10 mm otherwise the sample will follow the test normally but it will be marked with an placed on the record of the sample between the 1H and 2H results POSITION NUMBER SEQUENCE NUMBER RESULT 1H RESULT 2H IDENTIFICATION CODE OVERFLOW KINETIC FLAG In this way the Instrument indicates that the sample has an unstable performance and it is advisable to visually check the result or repeat the test 52 LENA Version 03 04 2003 3 7 HOW WORK Switch on the unit see section 3 1 and wait to the end of test cycle When a dot appears in the corresponding position we can load this position with a new tube first mix the tube like we describe i
10. 2003 8 LENA Version 03 04 2003 SECTION 1 INSTALLATION This Section describes installation applicable safety regulations and the transport packing dimensions of the LENA Physical location environmental conditions and electric power requirements are indicated for the correct installation of the Instrument 1 1 SAFETY REQUIREMENTS 1 2 INSTRUMENT REQUIREMENTS 1 3 TRANSPORT 1 4 INSTALLATION 9 LENA Version 03 04 2003 10 LENA Version 03 04 2003 1 1 SAFETY REQUIREMENTS NOTE Under no circumstances should the user deliberately modify the safety features of the Instrument Any modification of the Instrument will cancel the warranty or the technical service agreement if any In case the cable or the power supply begins to get damaged or broken they should immediately be replaced This Instrument is an electro mechanic device of which the user may not handle the internal parts For any technical issue contact the Technical Service of your Distributor whose staff is trained and qualified to carry out any repairs WARNING The Instrument must be disconnected from the power supply before starting any technical corrective work Operators should not attempt to repair faults or breakdowns In case of accidental spillage of the analyzed samples the spill must immediately be cleaned with an appropriate disinfecting solution to avoid the possible contamination of the laboratory personnel and Equipment Note The Instrument ca
11. LINEAR CHEMICALS S L Joaquim Costa 18 2 Planta 08390 Montgat Tel 34 93 469 49 90 Fax 34 93 469 34 35 www linear es e mail linear linear es LENA USER S MANUAL Random Access Autoanalyzer for Determination of the Erythrocyte Sedimentation Rate ESR 1 LENA Version 03 04 2003 2 LENA Version 03 04 2003 USER S MANUAL 1 INSTALLATION 2 DESCRIPTION 3 OPERATION 4 ERROR MESSAGES 5 ON LINE COMMUNICATIONS PROTOCOL 6 SERVICE AND MAINTENANCE CE CERTIFICATE 3 LENA Version 03 04 2003 4 LENA Version 03 04 2003 INTRODUCTION LENA is a random access autoanalyzer to determine the Erythrocyte Sedimentation Rate ESR capable of processing up to 16 samples simultaneously by means of an IR LED optical system LENA requires a minimal handling of the sample as the test is performed directly on the test tube admitting both open and vacuum tubes LENA allows the test to be made in accordance with two different operating modes 1 HOUR MODE 1 HOUR 2 HOURS MODE In both cases results are expressed in Westergren millimeters LENA is capable to process 40 samples per hour with uninterrupted sample loading as test positions are left free LENA features structured software to facilitate its learning and use with a clear and concise display The Instrument requires a minimum user s intervention and handling is simple and user friendly 5 LENA Version 03 04 2003 6 LENA Version 03 04 2003 7 LENA Version 03 04
12. as her analysis time 87 LENA Version 03 04 2003 88 LENA Version 03 04 2003 DECLARATION OF CONFORMITY ce Manufacturer Linear Chemicals SL Address Linear Chemicals SL Joaquin Costa 18 2 Planta 08390 Montgat Spain declares that the following product Product LENA Options All conforms to the following Directives and Regulations Directive 89 336 EEC Electromagnetic Compatibility EMC Directive 73 23 EEC Low Voltage Directive LVD Directive 98 79 EC In Vitro diagnostic medical devices IVD Generic EN 61010 1 1990 standards EN 55022 EN 50081 1 EN 61000 4 2 EN 50082 1 EN 61000 4 3 EN 50082 1 EN 61000 4 4 EN 50082 1 EN 61000 4 5 EN 50082 1 EN 61000 4 6 EN 50082 1 EN 61000 4 11 EN 50082 1 BEREITEN The purpose of this instrument is the determination of Erythrocyte Sedimentation Rate ESR in blood specimens The user himself or herself is ultimately responsible for the correct and controlled operation of the instrument Mongat 2004 07 02 Linear Chemicals SL Technical Director Manuel Rodriguez Doc 30 06 04 89 LENA Version 03 04 2003 90 LENA 01 00 01
13. computer copy the file from its origin disk A to the Windows office Then you will have the program icon on the main display of the Windows office Once installed we need to know in which communications port we have switched on the connecting wire COM1 COM2 etc The program has been shaped to work n the COM2 if the wire is connected to the COM2 nothing else has to be done Otherwise we have to open the program by pressing twice the icon with the mouse Once being opened press the file menu with the mouse press properties and change the COM2 connection to COMI or to the corresponding port To use the program open it by pressing twice the icon with the mouse and transmit the data which will appear on the display from the Instrument Then select the data with the mouse and print file menu print Once having finished press file and exit 68 LENA Version 03 04 2003 5 5 PRINTER If the L mode it s selected and a LINEAR THERMAL PRINTER it s connected you don t need to do nothing to work only connect the printer to the lena and connect the power supply to the printer and switch on To make the connection we need a cable with the a m features Before doing it consult the Printer Manual to see the arrangement of the pins in its connector in order to prepare the wire connector to the printer Also consult the communication features so they coincide with the Equipment ones they are quite common Be also sure that th
14. e port number through which the connection is made In the event of transmitting the data to a printer with serial port we have to configure the data transmission as PRT in the configuration menu 7 for its better functioning In the same way make sure that the printer port parameters and the wiring are the correct ones 7 MECHANICAL TEST The functioning of menu 7 is fully detailed on Section 6 2 of this Manual page 79 8 LR SENSORS TEST NOTE To have access to this function any test should not be going This function checks the proper operation of the Instrument optical system Press 8 at the main display and the following message will be displayed 5 gt ze BIER IE FE Be SVD NNR OOAN 44 LENA Version 03 04 2003 If you wish to enter this function confirm your choice by pressing IN otherwise press ESC DEL to return to the main display If you have confirmed by pressing IN you will access the function The display will show with a dash on position 1 indicating the position being checked If a black square B appears it indicates that there is a tube in this position To move to the next position press any numeric key and the dash will move to the following position If we press IN we can check all position in the same time If we take more than 30 seconds to press a key the programme having made a previous checking w
15. e type of protocol being selected in the Equipment is the P for the DPU414 as the more suitable one is the P Another possibility is to switch the Instrument on to a standard printer by means of the serial parallel converter In this case be sure that the type of selected protocol in the Equipment is the P one since the serial parallel converter is already delivered with the configuration and the connecting wire Then connect the parallel output centronics from the converter to the parallel port centronics of the printer the serial cable to the Instrument and the converter input and the feeder of the converter to a power source and to the converter If everything is correct start the printer place it on line and transmit data A maximum of 60 samples per page will be printed 69 LENA Version 03 04 2003 5 6 BAR CODE NOTE Bar code readers delivered by LINEAR CHEMICALS S L have already been adjusted in the plant to operate with the Equipment so the only necessary operation is to connect them to the Equipment in connector 4 and start the Instrument To enter I D codes by means of the bar code reader make the same operations as for its manual entering but read the bar code with the reader The DB9 male connector 4 of the Instrument has a standard connection to operate with any BAR CODE reader with series RS232 At first it will not be necessary to change the pins connection since it is a standard
16. go to wait status and stops the motor Then if detects the introduction a new tube makes a movement UP DONW and then starts the analysis In the first reader it controls if the filling levels it s correct If it s incorrect it printout Level Error After 24 minutes n 1H mode and 48 minutes in 1H 2H mode it printout the results and if don t have any other tube in work stops the reader If someone takes off a tube during the working time the instrument print out Sample Error The instrument detects new tubes only when it s in low position and then upgrades the LCD In that way when we put a new sample in the instrument or extract a finished sample the instrument can need some minute to show us the new status in the LCD When don t have analysis in process they stop the motor and wait for a new sample Maybe the instrument doesn t detect a new tube that it s in one position because his level it s out of range of reader s movement 86 LENA Version 03 04 2003 If before of the finish of the analysis one sample fall this level down of reader s movement the instrument printout a S E Sample Error that mains that don t detect the sample because it s out of range of the reader or some take off that sample But that it s produce in the second half of the analysis the instrument don t printout and error but the result will be 125mm h It s important to understand that each position has his couple of sensors and each one h
17. ic data being entered Esc Del If pressed once it deletes any numeric data being entered If pressed around 2 seconds it serves to exit any function when possible 2 3 WORKING PLANE Located in the upper part of the Instrument it features 16 positions for samples divided into two numbered rows 25 LENA Version 03 04 2003 2 4 REAR CONNECTOR PANEL Located at the rear of the Instrument it contains the following elements 1 Power connector 1 switch 2 2 Ventilation outlet 3 3 SUB D9 connector male for bar code reader 4 4 SUB D9 connector female for on line connection 5 26 LENA Version 03 04 2003 2 5 CHANGE WORKING CYCLE MODE 1H OR 1H 2H NOTE To switch on or switch off the Instrument do not modify the parameters previously configurated To consult the configuration press key 7 to enter the mechanical test menu The Instrument will display the message and press IN to enter or ESC DEL during 2 seconds to exit If IN is pressed the following display will appear Where B077 indicates the number of motor passes in the last cycle 0005 is the consumption meter L indicates the type of on line the equipment has selected the alternative one would be P or lt 0 1H indicates it is working with the 1 h cycle the alternative one would be 2H and if K appears it indicates that the kinetics control is activated
18. ill return to the main menu until reaching the lower position of the reader The status changes of the positions are displayed at once thus being easy to check if any position is not operating correctly To exit this function press key ESC DEL to return to the main display having previously displayed the checking display whereas the read out board goes back to its original position 9 PARTIAL AND FINAL READINGS This function allows you to visualize the complete record of a sample with the 1H or 2H results if any and of the 6 partial readings made by the Instrument during the analytical cycle 45 LENA Version 03 04 2003 Access to these partial readings provides the chance to follow the test evolution The Instrument only displays the partial readings of the positions which are in use up to a maximum of 16 samples but it holds in memory the remainder of the patient record up to 240 samples Press 9 at the main display The following message will be displayed If you wish to enter the menu confirm your choice by pressing IN otherwise press ESC DEL to return to the main display If you have confirmed by pressing IN the following message is displayed Enter the position number of the sample we wish to display If the position number has two digits it will not be necessary to press IN as the Instrument will automatically accept the position If we make a mistake when entering a digit p
19. llowing message is displayed If you wish to enter the menu confirm by pressing IN Otherwise press ESC DEL to return to the main display If you confirm your selection by pressing IN the following message is displayed If you do not wish to enter an ID to a specific sample simply press IN and the last memorized sample will be displayed if memory is deleted or whether it is the first sample of the day we will return to the first one POS 1 SEC 1 38 LENA Version 03 04 2003 Then the complete memory record of this sample will be displayed and the cursor will be placed over the sequence number so that you can enter the ID number If no one has been entered the ID code will be represented by dashes POSITION NUMBER SEQUENCE NUMBER RESULT 1H RESULT 2H IDENTIFICATION CODE At this point you can enter the ID via keyboard or by using a bar code reader Enter the ID by pressing the numeric keys and press IN to confirm your selection and go to the following sample If you do not wish to enter an ID to a specific sample simple press IN without entering any ID number The system will take you to the following sample If you make a mistake when entering a digit press ESC DEL The cursor will return to the beginning of the record so that you can re enter the number correctly If you wish to exit the function at any time press the key ESC DEL to return to the main display The Instru
20. ment has a capacity for 240 samples arranged from SEC 1 to SEC 240 If we want to recognize or rectify the ID of a sample already identified from the main menu press 1 and IN from the main menu and when the following message is displayed introduce the sequence number of the sample to be entered and press IN 39 LENA Version 03 04 2003 If the sequence number has three digits it will not be necessary to press IN since the system will automatically jump to the selected sample At this stage introduce the ID number and continue with the following sample 2 RESULTS CORRECTION At the main display press key 2 and the following message will be displayed Here we can confirm by pressing IN otherwise press ESC DEL to return to the main display If you have confirmed by pressing IN the following message will be displayed Now enter the sequence number of the first sample to which you want to correct the result If the sequence number has three digits it will not be necessary to press IN since the system will automatically jump to the selected sample At this point the following message will be displayed POSITION NUMBER SEQUENCE NUMBER The cursor will be placed on the Ih result record so that it can be modified Enter the new result and press IN If the result has three digits it is not necessary to press IN to go to the following sample or the 2h result
21. n section 3 2 Before that we can introduce the ID_CODE for that sample see section 3 4 1 When this sample is recognized by the instrument with the black square W in their position the sample starts his cycle If the filling level of that sample it s not correct the instrument show us E in the specific position At the end of analysis the instruments show us F in the specific position and a the same time the instrument send trough the serial port this result to the printer o a computer It s possible too to see the results in Partial Menu key 9 see section 3 4 9 Then we can take off the finished sample After some minute a appear in that position to show us than that position it s empty Then we can reload this position with a new tube The sequence list number of that sample has the sequence of the predecessor plus 16 Note It s very important to wait until the instrument shown lt 69 Tn the corresponding position because in that way the instrument recognize the position empty and it s able to accept another sample Note Don t forget to mix properly the samples 53 LENA Version 03 04 2003 Data can be transmitted to the computer system of the laboratory So it is necessary to know the communication protocol Section 5 of this Manual Data can also be transmitted to any computer with a free serial port only adjusting the port parameters section 5 on the HYPERTERMINAL prog
22. n be cleaned with a water and soap solution or with 70 alcohol Do not use a larger alcohol concentration as it could damage the cover of the Equipment 11 LENA Version 03 04 2003 12 LENA Version 03 04 2003 1 2 INSTRUMENT REQUIREMENTS The LENA must be placed on a perfectly flat and level surface not exposed to any vibrations It is important for the rear of the Instrument to have sufficient clearance to allow the air to circulate properly Recommended clearance for a good air circulation is approximately 15 cm Weight 4 Kgs Width 31 cm Height 18 cm Depth 31 cm Main voltage 100V 240V Frequency 47 63 Hz Frequency line variation 2 Hz Current 0 5 A Energy consumption 10 VA The LENA has been designed to operate under certain environmental conditions Room temperature 15 32 C Max relative humidity 80 at 32 C 13 LENA Version 03 04 2003 14 LENA Version 03 04 2003 1 3 TRANSPORT The packing of the LENA Weight 11 Kgs Dimensions 41x32x41 cm contains Instrument power cable User s Manual with QC certificate and CE Certificate Previous to the installation of the Equipment a visual packing inspection is recommended in order to detect any abnormality that could affect the Instrument If any problem is observed notify the supplier before accepting the unit If it is necessary to prepare the Instrument for a new transport it must be operated without any test on the move for at least two
23. ome minute we can see in the printer a list of the recent mechanical test When the instrument has made some movements you can check if the variation between movements it s OK A variation greater than 10 hexadecimal steps it s abnormal It s possible make that test during an analysis If the repetibily of that test it s not good the results can be erroneous Check the conditions of the axis and her bearing maybe are dusty or not good lubrificate If after some minute of moving up or down the instrument don t detect the mechanical sensor it show to us ERROR in the second line of the main screen and change the direction of the movement It means that the instrument have some mechanical problem 85 LENA Version 03 04 2003 6 7 HOW THE INSTRUMENT WORKS When we switch on the instrument the micro set up the LCD display Controls if there s some analysis in process o some tube in the instrument if there s one go directly to the main screen and continue the analysis process if there s in time If don t have tubes in the instrument check if we would like to change the analysis mode 1H or 1H 2H and send online the head report After those controls if there s a change of the date and if it s a new day clear the memory Then test the mechanic going up send the second part of the header and down and when arrives down go to main screen and it s ready to work Then makes a new up down cycle and if don t detect any tube
24. ome sample does not comply with the above conditions the Unit and the message S E will be printed will refuse it The activation of the SKS System will be indicated with an Asterisk on the mechanical tests SKS FLAG NOTE 1 The SKS system is exclusively designed to finalize the tests of a sample thus obtaining the final result Therefore when the SKS system is activated the results of the partial readings must be discarded 49 LENA Version 03 04 2003 NOTE 2 If the user disconnects by mistake the Unit during the analytical cycle the SKS system will be activated thus allowing to finalize the test under way NOTE 3 If the breakdown in the current is higher than the duration of the analysis cycle it is necessary to repeat the test of the samples 50 LENA Version 03 04 2003 3 6 KINETICS CONTROL The Instrument is equipped with a kinetics control system allowing to check the linearity of the tests being made When the equipment leaves the Factory the kinetics control system is deactivated If the kinetics control system is activated Section 6 2 explains how to activate it and how to check if it has been activated the Instrument checks that between two successive readings approx 2 minutes the red blood cells fallout is not higher than 10 mm otherwise the sample will follow the test normally but it will be marked with an placed on the record of the sample between the
25. one These configuration is PINS OF THE BAR CODE READER TX PIN 2 transmission GND PIN 5 grond VCC PIN 9 supply 5 Volts 70 LENA Version 03 04 2003 It could be necessary to change the features of the reader communication interface To do so the reader is delivered with a programming manual on the basis of reading bar code labels Connect the reader to the Instrument start it and read the corresponding labels to configurate the reader as follows e Type of communication RS 232 e Baud Rate 9600 e Data Bits 8 bits e Parity Even e Handshaking No e Stop Bit 1 e End of Record or End of Text CR Do not enable the transmission of any other control signal We usually have to read a BEGINNING label and having read the configuration codes a FINAL label or to save configuration Once the Equipment being configurated stop the Instrument and restart it to test the reader 71 LENA Version 03 04 2003 72 LENA Version 03 04 2003 73 LENA Version 03 04 2003 74 LENA Version 03 04 2003 SECTION 6 SERVICE AND MAINTENANCE 6 1 GENERAL 6 2 INSTRUMENT CONFIGURATION 6 3 OPEN THE INSTRUMENT 6 4 ELECTRONIC PARTS 6 5 MECHANIC PARTS 6 6 TEST THE INSTRUMENT 6 7 HOW THE INSTRUMENT WORKS 75 LENA Version 03 04 2003 6 1 GENERAL The Instrument has been designed to need the minimum maintenance during several years although there are some factors which can influence the duration of this period The Instr
26. osition 41 LENA Version 03 04 2003 If you make a mistake when entering a digit press ESC DEL and the cursor will return to the beginning of the record to introduce the correct position If you enter a position number higher than 16 the Instrument will not accept it Once the position number being accepted the Instrument will go automatically back to the main menu To exit the function press ESC DEL to return to the main display 5 SET ADJUST DATE AND TIME NOTE To have access to this function any test should not be going Press key S at the main display and it will appear If you wish to enter the menu confirm by pressing IN otherwise press ESC DEL to return to the main display If you have confirmed your choice by pressing IN the display will show YEA MONTH DAY HOUR MINUTE CONDS The cursor will wait on the underline of the display so that you may enter the data as they appear above Once all the data being entered the System will memorize them and will automatically return to the main display If you make a mistake when entering a digit press ESC DEL for the cursor to return to the beginning of the record to re enter the correct data To exit this function press ESC DEL to return to the main display 42 LENA Version 03 04 2003 6 ON LINE TRANSMISSION RESULTS Press 6 at the main display The following message will be displayed If you wish to en
27. ram and printing from this program A LINEAR CONNECTION program is also available with the parameters being adjusted for its functioning and being only necessary to check the port number through which the connection is made Note make sure that the printer port parameters and the wiring is the correct ones 54 LENA Version 03 04 2003 55 LENA Version 03 04 2003 56 LENA Version 03 04 2003 SECTION 4 ERROR MESSAGES This Section describes the error messages which may be generated 4 1 ERRORS 4 2 ANALYTICAL ERRORS 57 LENA Version 03 04 2003 58 LENA Version 03 04 2003 4 1 ERRORS 1 L E Level Error It indicates that the blood level is not correct Fill to the correct level and repeat the test If this error message is displayed for a position with no sample tube call the Technical Service 2 S E Sample Error It indicates that a sample has been removed before completing the test Repeat the test If this error message is displayed for a position with no sample tube call the Technical Service 3 ERROR It appears in the second line of the main screen and indicates that the reading plate has not detected the upper or lower mechanical sensor If this error message is displayed stop and then restart the Instrument If the error persists call the Technical Service NOTE This error may occur if a tube breaks and some parts remain inside it or whether some object falls down or is introduced
28. ress ESC DEL for the cursor to return to the beginning of the record and then re enter the correct position The Instrument will not accept a position number higher than 16 If we are working with the 1H cycle every partial reading has been made and therefore the test has finished the following message will be displayed SEQUENCE N RESULT 1H ID CODE POSITION N PARTIAL 24 MIN 12 MIN 16MIN 20 MIN RESULT 1H 46 LENA Version 03 04 2003 In case we are working with the 1H 2H cycle every partial reading has been made and therefore the analysis has finished the following message will be displayed POSITION N SEQUENCE N RESULT 1H RESULT 2H ID CODE 48 MIN 8 MIN k 16 MIN RESULT 1H 32 MIN 40 MIN RESULT 2H If the tests are not completed we only display data being obtained up till then If you wish to printout de data of the sample with the partial graphic press key 3 If you wish to transmit on line the two records press key 6 Press IN to display the following sample records and ESC DEL to display the records of the preceding sample 0 CLEAR MEMORY Up to 240 samples and 16 records of partial readings can be saved in the Instrument memory When we delete memory the default sequence number being memorized in the Instrument starts from the first sample that is POS 1 SEC 1 The Instrument clears memory when it is switched on every new day If the Instrument i
29. s in motion when changing from one day to another the memory will only be deleted when the Instrument stops and restarts again To delete the memory on the main display press key 0 The following question will be displayed 47 LENA Version 03 04 2003 If you wish to enter this function confirm by pressing IN otherwise press ESC DEL to return to the main display Warning If you run this function all data stored in memory will get lost and the analytical cycle will be aborted While this function is being run the following message will be displayed Once completed the System will automatically return to the main display 48 LENA Version 03 04 2003 3 5 SKS SAFE KEEPING SYSTEM The Instrument has a protection system SKS allowing finalizing the tests which are going in the event of a breakdown in the current during the analytical cycle After any break in the current and once being repaired the SKS sytem will be activated It will operate in a different way and according to the following assumptions If there are no tests in motion the Unit resets normally If there are tests going the Unit begins to work in the default analysis mode checks that the initial level has been memorized for every sample and that the analytical cycle of everyone has not finished If these conditions are fulfilled the Instrument will complete and print the results of the samples test In case that s
30. s placed in the backside of the IR Board and it s important that have a good alignment to the up flag to detect de up position The mechanical sensor down it s placed in the bottom front side of the IR Board and it s important that have a good alignment to the down flag to detect de down position It s important to maintain the mechanical sensor and IR leds and receptors clean and not exposed at direct light 84 LENA Version 03 04 2003 6 6 TEST THE INSTRUMENT e IR READER TEST You can see how works the Infrared Test in page 44 That test allows us to know if the couple Infrared Leds of every position it s working properly To be sure that I R Leds work ok it s recommendable to move the I R cable up and down because maybe it s working properly in static position but in movement not Note the tube must be filled with blood o something not Transparent e MECHANIC TEST To enter in Mechanical Test press key 7 to enter the mechanical test menu Then press IN to confirm and enter in Mechanical Test Screen The first four digits at the left side of the second line for example B9A7 indicates the number of step motor in the last movement in hexadecimal format The movement can be up to down or down to up When we are in that screen and the first key that we press it s 9 the steps of the motor are updated and send it to the printer and in the LCD at the end of every movement In that way after s
31. serial port it s driving trough a chip in Main Board ST232C The IR Board are driving like a matrix trough chips 374 and 4051 and the reader signal it s compared to a reference signal in other chip LM311 before input in Micro In Main Board it s located the Micro 87C52 how do all calculation and control functions and a backup memory M48T08 to maintain the data In the IR Board the blue leds are the emitters and the white leds are the receptors The emitters electrically are grouped in groups of four emitters each one 82 LENA Version 03 04 2003 6 5 MECHANIC PARTS LEAD SCREW STEP MOTOR MECHANIC SUPPORT The Mechanical Support with their axis the IR carriage with their bearings and the Tubes Support compose the mechanical parts The Step Motor converts electrical impulses to axial movement and moves the lead screw trough the coupling The lead screw converts axial movement to linear movement and move up and down the IR Board The mechanical support its fixed at the instrument trough 2 screws in bottom The I R Board it s fixed at carriage trough four screws in bottom To dismount the I R Board we need to dismount the flag of the sensor up ant take off to the up the carriage from their axis It s important that the axis and the bearings are clean and lubrificated with solid greases for example lithium grasses Do not lubrificate the lead screw 83 LENA Version 03 04 2003 The mechanical sensor up it
32. ter the menu confirm your choice by pressing IN otherwise press ESC DEL to return to the main display If you have confirmed by pressing IN the following message will be displayed The sequence number of the first sample to be sent and afterwards the sequence number of the last one will be entered in the second row If the sequence number has three digits it will not be necessary to press IN since the System will automatically jump waiting for the number of the last sample to be sent If you make a mistake when entering a digit press ESC DEL for the cursor to return to the beginning of the record and then re enter the correct sequences After entering these sequence numbers the Instrument will start to send data displaying the following message When the transmission is completed the System will automatically return to the main display To exit this function press ESC DEL to turn back to the main display 43 LENA Version 03 04 2003 Data can be transmitted to the computer system of the laboratory So it is necessary to know the communication protocol Section 5 of this Manual Data can also be transmitted to any computer with a free serial port only adjusting the port parameters section 5 on the HYPERTERMINAL program and printing from this program A LENA CONNECTION program is also available with the parameters being adjusted for its functioning and being only necessary to check th
33. through the opening of the tubes 59 LENA Version 03 04 2003 4 2 ANALYTICAL ERRORS Low results a Possible blood clot in the sample Repeat the test with a new sample b When more than 2 hours have elapsed from the taking out of the sample until the test c Insufficient sample amount which alters the proportion between blood and anticoagulant affecting the test result High results a Sample not shaken correctly b If the Instrument has been installed on a surface that is not perfectly level A 3 inclination can increase the ESR by 30 c Excessive sample amount which alters the proportion between blood and anticoagulant affecting the test result 60 LENA Version 03 04 2003 61 LENA Version 03 04 2003 62 LENA Version 03 04 2003 SECTION 5 ON LINE COMMUNICATIONS PROTOCOL This Section describes the different connection possibilities of the Instrument to the printer computer or bar code reader 5 1 GENERAL 5 2 ON LINE FEATURES 5 3 ON LINE DATA PACKAGE CONTAINS 5 4 CONNECTION TO A PERSONAL COMPUTER 5 5 PRINTER 5 6 BAR CODE 63 LENA Version 03 04 2003 64 LENA Version 03 04 2003 5 1 GENERAL To transmit data enter menu 6 and select the samples to be sent through their sequence number Once being selected the transmission will automatically be made provided that the linkage has already been established The Instrument has 3 standard transmission modes e The LINEAR PRINTER L mode suitable
34. tted once the connection is established CR START LF CR Then the full record of every selected sample is transmitted Every sample record is composed of 24 BYTES followed by LF and CR It is a text record and its format is as follows PP _ SSS _RIH R2H CCCCCCCCC LF CR where _ equals a blank space 20h PP equals the position on the grate 1 to 16 SSS is the sequence number of the sample 1 to 240 R1H is the 1 hour result 1 to 200 R2H is the 2 hour result 1 to 200 If no results are available blank spaces are transmitted CCCCCCCCC is the ID code of the sample with a maximum of 9 digits If no ID was entered 9 blank spaces are transmitted LF OAh and CR ODh are transmitted at the end of every record The end of the sample data transmission is indicated by ESC OBh and LF OAh 67 LENA Version 03 04 2003 5 4 CONNECTION TO A PERSONAL COMPUTER Connecting features are the same The type of ON LINE ONL transmission is used To make this connection we have serial connecting wires for 9 and 25 pins port as well as the LENA CONNECTION programme To perform the connection we need first the correct wire with the connector for the 9 or 25 female pins computer this connector will depend on the computer to which it is connected the one that is connected to the Instrument will always be of 9 male pins To install LENA CONNECTION in your
35. ument has to operate in a clean ambiance and with few dust as it could be adhered to the reader and movable parts of the machine So it is adviseable to cover the Instrument when no used Clean the Instrument with a humid cloth when needed Avoid to spill liquids or reagents over the Equipment and above all the breakdown of tubes The stability of the mains in the laboratory affects the life of the electrical components of the Equipment So it is desirable to keep it away to the maximum from other equipments generating electromagnetic disturbances such as centrifugues autoclaves and equipments not marked CE and generally equipments using electronic power devices such as motors pumps electrovalves and compressors 76 LENA Version 03 04 2003 6 2 INSTRUMENT CONFIGURATION NOTE To switch on or switch off the Instrument does not modify the parameters previously configured To consult or change the configuration press key 7 to enter the mechanical test menu The Instrument will display the message and press IN to enter or ESC DEL during 2 seconds to exit If IN is pressed the following display will appear then pres 5 times IN and the configuration screen appears In the first line we can see the headers and just below the headers we can see the selection IDI means language Then ENG it s English FRA French POR Portuguese ITA Italian TUR Turkish
36. ut of the 30 minutes result Then lt 30 enable the automatic printout of the 30 minutes result And a space means without automatic printout of the 30 minutes result Every time than we press 6 key the selection changes to the next one To setup that parameter the motor must be stopped without any analysis in work K means Kinetic control section 3 6 page 51 Then K enables Kinetic control And disable kinetic control Every time than we press 7 key the selection changes to the next one 78 LENA Version 03 04 2003 Le it s the number of steps how are settled the error level it s a hexadecimal number The factory setup it s 39 If we need more tolerance to don t have so many errors we need to setup a lower number If we need less tolerance we need to setup a greater number To increases the number press 8 and to decreases the number press 0 if we are pressed before 8 To setup that parameter the motor must be stopped without any analysis in work Te Fa every time we press Esc Del below Te appears the temperature in the instrument Below Fa we can see the factor to adjust that temperature To increases the factor and the temperature press 9 and to decreases the factor and temperature press 0 if we are pressed before 9 To setup that parameter the motor must be stopped without any analysis in work To come back to
37. utes have elapsed from the start of the test and depending on the selected cycle the end of the test is reported with an F in the corresponding position on the display 36 LENA Version 03 04 2003 3 3 STATUS DISPLAYS In the main menu the following message is displayed Here the positions status of the working panel is displayed The asterisk indicates that this position is free every black square W shows that this position is in use an F indicates that the test has finished in this position and an E indicates the existence of an error message see Section 4 error messages Example In this case the position 2 has finalized position 12 presents an error positions 6 and 9 are in use and the remaining ones are empty This display is updated approx every minute and each time that we go back to it from the menu That is every minute approx the new tubes being detected and finalized appear on the display 37 LENA Version 03 04 2003 3 4 FUNCTIONS Whenever you are at the main display every numeric key provides access to the following functions 1 SAMPLES ID 2 RESULTS CORRECTION 3 PRINT RESULTS in case of LINEAR or PRINTER online mode 4 REPETITION OF A SAMPLE 5 SET ADJUST DATE AND TIME 6 ON LINE TRANSMISSION OF RESULTS 7 MECHANICAL TEST 8 LR SENSOR TEST 9 PARTIAL AND FINAL READINGS 0 CLEAR MEMORY 1 SAMPLES ID At the main display press 1 The fo
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