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1. 1 User s manual 3 7 TIME Press the keys N or Y till Time is displayed 1T T Calibration If calibration is wanted press OK CALIBRATE Y N When pressing Y it is displayed REF T 0 The cursor is placed in the tens of percentage To modify it use the arrows f and To go to units press Y To validate press OK The programmed time is displayed It goes to the main display for Time 1T T Measuring If the sample identification is wanted press f to increase it or to decrease it Press RESET to activate the chronometer If the incubation time was programmed it will be displayed To start the countdown press OK At 20 left a bip will sound When the countdown will be finished it will be set to zero It is displayed IT T 000 0 Dispense the starter reagent to activate the chronometer When the clot is detected the chronometer stops 13 bio bas 1 User s manual IT T 16 9 If a reference time has been previously programmed the ratio is displayed when pressing VAL IT R 0 84 If a new sample is wanted to be run press RESET and the chronometer will be activated The sample identification is increased in one unit from the previous one 2T T 000 0 Once all readings are done to exit from the T program press N and Y bio bas 1 User s manual 4 SPECIAL UTI
2. 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 DAILY CONTROL Read a control MONTHLY CONTROL Read a high control Read a low control ANNUAL CONTROL Clean the optical group Read a high control Read a low control Operator TAS NOTES
3. asterisk indicates so Dispense into the cuvettes the needed volume of reagent or sample Look the specific packaging s It is very important to avoid air bubbles formation because they can stop the instrument before the clotting time It is recommended to use a pipetting system that does not introduce bubbles The cause is very often the pipetting pressure That is why it is recommended to pipette AGAINST THE CUVETTES WALL or use a piston pipette when first reagent plasma is added and PIPETTE IN A COMPLETE VERTICAL POSITION when adding the starter Do not pipette with a disposable tip pipette on the cuvette bottom because bubbles will be formed In case any air bubble is formed gently knock the cuvette bottom against any table or any flat surface to make the bubbles to reach the surface of the liquid When the thermostatisation time is finished the cuvette is placed on the reading well Be sure that it reaches well the bottom Cover 1t with the cap press RESET The chronometer remains inactive for some seconds delay time programmed on the display it appears and then it shows 000 0 At 6 bio bas 1 User s manual this moment the reagent or plasma is added with a disposable tip pipette leaving the liquid to get down with one blow and all the reaction starts at the same time The addition MUST be done with a disposable tip pipette DO NOT USE piston pipettes nor glass ones because the liquid falls drop by drop not with
4. Ctra Santa Coloma 7 E 17176 Sant Esteve de Bas Girona Spain Tel 34 972 69 08 00 Fax 34 972 69 00 99 www spinreact com bio bas 1 USER S MANUAL bio bas 1 User s manual INDEX 1 INTRODUCTION 3 1 1 General 3 1 2 Theory of the instrument functioning 3 1 3 General description of the instrument 3 1 4 Functioning criteria and limitations 4 2 INSTALLATION 5 2 1 Recommendations on reception 5 2 2 Preparation before the installation 5 3 WORKING 6 3 1 Samples and reagents 6 3 2 Measurement 6 3 3 Switching on 7 3 4 Prothrombin Time 8 3 5 Activated Partial Thromboplastin Time 10 3 6 Fibrinogen 11 3 7 Time 13 4 SPECIAL UTILITIES 15 4 1 Prothrombin Time 15 4 2 Activated Partial Thromboplastin Time 17 4 3 Fibrinogen 18 4 4 Time 20 4 5 Language 21 4 6 By default 21 5 CONSUMABLES 23 6 MAINTENANCE 23 7 PROBLEMS AND SOLUTIONS 24 8 COMPLEMENTARY INFORMATION 24 bio bas 1 User s manual 1 INTRODUCTION 1 1 GENERAL SPINREACT bio bas 1 coagulometer is an instrument created to determinate the most important parameters run in plasma coagulation methods Prothrombin Time or Quick Time PT Activated Partial Thromboplastin Time APTT Thrombin Time TT Fibrinogen Concentration FB and all coagulation methods whose principle is the determination of a clotting time bio bas 1 stores the calibration curves for Prothrombin Time and Fibrinogen Concentration which means no calculation is needed to be done by the u
5. LITIES Pressing at the same time both arrows f and from the main menu it is possible to get into a technical menu that allows to change certain parameters of the instrument configuration It is displayed PT Pressing the key Y the parameters change following this order it is possible to go back pressing N PT PTT FB T LANGUAGE BY DEFAULT After BY DEFAULT it goes to the main program To choose any of the parameters press OK when it is displayed 4 1 PROTHROMBIN TIME When PT is chosen it is displayed N POINTS When pressing the keys f and the number of points is increased or decreased To accept press OK The percentage of first point will appear 100 1 To modify the value use the vertical arrows f and to change the number press the horizontal arrow Y and confirm pressing OK The time defined for the first point is displayed bio bas 1 User s manual T 12 1 To modify the value use the vertical arrow f and to change the number use the horizontal arrow Y and confirm pressing OK The activity percentage for the second point is displayed 25 2 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK The defined time for the second point is displayed T 24 2 To modify the value us
6. a blow and all the reaction does not start at the same time The addition is done introducing the tip of the pipette through the cap orifice and maintaining the pipette in vertical position pipette for the dosage to fall in the central part of the cuvette a pipette inclination would make the sample slide on the cuvette wall producing wrong results The pipetting MUST NOT BE energetic nor extremely gently If the cap is lost or it is not wanted to be used do always pipette in the CENTRAL PART OF THE CUVETTE AND IN VERTICAL POSITION When the reagent and the plasma are in contact a O D variation is produced that automatically activates the digital chronometer and the magnetic mixer When the clot starts to be formed an O D variation is produced and stops the chronometer and the mixer The clotting time is displayed NOTE Plasma thermostatisation The reagents producers indicate the incubation time rules This time must not be higher than the established one If the plasma remains more than 5 minutes on the thermostat an evaporation of the aqueous part takes place often this phenomena can be observed on the cuvette wall and it makes the times to be shorter due to the plasma concentration It is also important to obtain a perfect repeatability All the plasmas must have the same incubation time because if one plasma is thermostated at 3 and another one at 5 the results will be different In case the working volume makes difficult to
7. creased or decreased To go to the next number tens press Y If it is needed go to the third number When finished press OK The time is displayed TIME 8 If it is necessary to change the time use the keys f and Y To finish press OK The second point is displayed bio bas 1 User s manual CONC 200 2 It is modified like the first point The time for the second calibration point is showed TIME 15 The time is modified as for the first point Press OK to confirm it and it goes to the measuring display Measuring If the sample identification is wanted to be changed press f to increase the value or to decrease it Press RESET to activate the chronometer If the incubation time was programmed it will be displayed To start the countdown press OK At 20 left a bip will sound When the countdown will be finished it will be set to zero It is displayed 1FB T 000 0 Dispense the starter reagent for the chronometer to start When the clot is detected the chronometer stops 1FB T 93 When VAL is pressed the result is shown as CONCENTRATION LEB C 3373 If a new sample is wanted to be run press RESET and the chronometer will be activated The sample identification is increased in one unit from the previous one 2 FB T 000 0 Once all readings are done to exit from the FB program press N and Y gt bio bas
8. d point is displayed TIME 5 2 The security time is requested It is the time during which optical variations do not stop the instrument By default is 5 SAFET 5 bio bas 1 User s manual To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK The delay time is requested It is the time since RESET is pressed after placing the cuvette in the reading position till the chronometer is set to zero By default is 3 but it could be longer if the reagent presents a high turbidity DELAY 3 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK At the end the incubation time is requested In case it is programmed a value different from zero the chronometer will make a countdown to indicate the exact moment the starter should be added The minimum value that may be introduced is 30 seconds INCUB T gt To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK It goes to the initial display where FB is displayed Pressing several times Y it goes to the main display 4 4 TIME From the T display press OK to get into the configuration parameters to be modified Pressing OK again the reference time is requested It is optional and i
9. e between 15 and 35 C without excessive humidity b Technical requirements The connection to the electrical power should be made with the included connection cable and only if earth connection exists bio bas 1 User s manual 3 WORKING 3 1 SAMPLES AND REAGENTS Samples Citrate plasma is used poor in platelets obtained from venous puncture The anticoagulant used should be Sodium Citrate 3 8 in a ratio 1 part of citrate and 9 parts of blood Centrifuge as soon as possible for 10 at 3 000 r p m in polystirene tubes Quickly prepare the plasma transfer 1t into clean and dry polystirene tubes for better conservation and homogenisation The maximum time recommended from extraction till measurement is 3 4 hours Samples could be stored in the fridge but never frozen Reagents The thermostatisation time should be well controlled if indicated in the packaging insert Reagents must be all at room temperature and well homogenised before using them Accessories The plastic black cap is used to fix the pipette tip and maintain it in vertical position when adding the starter It could not be necessary if pipetting is done in the middle of the reaction cuvette in vertical position and without touching the reagent plasma on the cuvette 3 2 MEASUREMENT Place the reaction cuvettes required for the samples to be run in the thermostat Add a stirring bar into every cuvette and wait for the instrument to be at 37 C the
10. e method gt Y changes the method OK validation RESET reset the chronometer to zero 1 4 FUNCTIONING CRITERIA AND LIMITATIONS The instrument has an accuracy of 1 tenth of a second As it is a manual instrument the influence of pipetting and the reagents conditions are very important and to obtain a good repeatability on results it is necessary to always follow the manufacturer s indications and the working method bio bas 1 User s manual 2 INSTALLATION 2 1 RECOMMENDATIONS ON RECEPTION bio bas 1 should be stored in a dry place no extreme temperatures and if it possible not directly under the sunlight During the unpacking the instrument and all accessories should be checked and in good conditions The starter kit accessories are 2 fuses of 2 amperes 1 plastic cover 1 user s manual 1 connection cable 1 black cap 50 coagulation cuvettes 50 stirring bars In case of any anomaly please contact your distributor and fulfil the return tag included in the box Store it in its box It is recommended to keep it covered when no working to avoid dust to get into the reading zone 2 2 PREPARATION BEFORE THE INSTALLATION a Conditions of the installation place bio bas 1 should be installed in a place free of vibrations and without direct light as the detection system is based on the variation of the absorbance of light and therefore all external interferences should be avoided The surrounding temperature should b
11. e the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK Then the ISI is requested It is a value given by the reagents manufacturer and it is used to calculate the INR To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK ISI 2 The security time is reguested It is the time during which optical variations do not stop the instrument By default is 5 SEF T 5 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK The delay time is reguested It is the time since RESET is pressed after placing the cuvette in the reading position till the chronometer is set to zero By default is 3 but it could be longer if the reagent presents a high turbidity bio bas 1 User s manual DELAY 3 To modify the value use the vertical arrows 7 and to change the number use the horizontal arrow Y and confirm pressing OK At the end the incubation time is requested In case it is programmed a value different from zero the chronometer will make a countdown to indicate the exact moment the starter should be added The minimum value that may be introduced is 30 seconds INCUB T gt To modify the value use the vertical arrows f and to change the number use the ho
12. follow the incubation standardisation it is possible to work with plasmas at room temperature 20 25 C after taking the reference at the same temperature 3 3 SWITCHING ON Place the instrument on a stable place away from direct light Plug it and switch it on using the switch placed on the left rear side 1 PT T lt The first number 1 indicates the sample identification PT indicates the method T is the chronometer When the working temperature is reached the final signal is an asterisk IPT T 3 4 PROTHROMBIN TIME bio bas 1 User s manual Press N or Y keys till PT is displayed IPT T Calibration If calibration is wanted press OK CALIBRATE Y N For an affirmative answer press Y gt The first calibration point 100 is displayed Yo 100 1 When pressing OK the defined time is showed TIME 12 00 1 The cursor is placed on the first number With keys and it can be increased or decreased The order is blank space decimal point 0 1 9 To go to next number press Y When finished press OK The second calibration point is displayed 25 2 The cursor is placed in the tens of percentage To modify it use the arrows f and To go to units press Y To validate press OK The programmed time is displayed TIME 23 00 2 Modify it as done fo
13. n the first number With keysf and it can be increased or decreased To go to next number units press Y When finished press OK It goes to the PTT main menu 1 PTT T Measuring If the sample identification is wanted to be changed press f to increase it and to decrease it Press RESET to activate the chronometer If the incubation time was programmed it will be displayed To start the countdown press OK At 20 left a bip will sound When the countdown will be finished it will be set to zero It is displayed 1 PTT T 000 0 Dispense the starter reagent for the chronometer to start When the clot is detected the chronometer stops 1 PTT T 30 4 Pressing VAL the result is shown as RATIO if a reference time was introduced bio bas 1 User s manual 1 PTT R 1 09 If a new sample is wanted to be run press RESET and the chronometer will be activated The sample identification is increased in one unit from the previous one 2 PTT T 000 0 Once all readings are done to exit from the PTT program press N and Y 3 6 FIBRINOGEN Press the keys N or Y till Fibrinogen is displayed 1FB T Calibration If calibration is wanted press OK CALIBRATE Y N When answering YES it is displayed CONC 400 1 The cursor is placed in the first number hundreds Using the keys f and the value is in
14. r the first point of calibration Finally press OK It goes to the main display of PT bio bas 1 User s manual IPT T Measuring If the sample identification is wanted to be changed press f to increase it and to decrease it Press RESET to activate the chronometer If the incubation time was programmed it will be displayed To start the countdown press OK At 20 left a bip will sound When the countdown will be finished it will be set to zero It is displayed 1 PT T 000 0 Dispense the starter reagent for the chronometer to start When the clot is detected the chronometer stops IPT T 129 If result is wanted to be shown as percentage ratio and INR the VAL key should be pressed The following displays will appear in a consecutive way IPT 80 3 IPT R 107 IPT I 1 16 If a new sample is wanted to be run press RESET and the chronometer will be activated The sample identification is increased in one unit from the previous one 2PT T 000 0 Once all readings are done to exit from the PT program press N and Y 3 5 ACTIVATED PARTIAL THROMBOPLASTIN TIME bio bas 1 User s manual Press the keys Nor Y till PTT is displayed 1 PTT T Calibration If calibration is wanted press OK CALIBRATE Y N When pressing Y it is displayed REF T 0 The cursor is placed o
15. rizontal arrow Y and confirm pressing OK It goes to the initial display where PT is displayed Pressing several times Y it goes to the main display 4 2 ACTIVATED PARTIAL THROMBOPLASTIN TIME From the PTT display press OK to get into the configuration parameters to be modified PTT Pressing OK again the reference time is requested It is optional and it is used to give the final result as a RATIO between the sample time and the time of a normal pool of plasmas REF T 0 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK bio bas 1 User s manual The security time is requested It is the time during which optical variations do not stop the instrument By default is 5 SEF T 5 To modify the value use the vertical arrows 7 and to change the number use the horizontal arrow Y and confirm pressing OK The delay time is requested It is the time since RESET is pressed after placing the cuvette in the reading position till the chronometer is set to zero By default is 3 but it could be longer if the reagent presents a high turbidity DELAY 3 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK At the end the incubation time is requested In case it is programmed a value different from zero
16. rk should be protected with the plastic cover to avoid dust specially in the reading zone The a m cover should be placed some minutes after switching the instrument off Be aware to not pipette any product in the instrument if the cuvette is not placed in the reading zone C Recommended spare parts It is recommended to have a couple of fuses 23 bio bas 1 User s manual 7 PROBLEMS AND SOLUTIONS PROBLEMS POSSIBLE CAUSES SOLUTIONS Time obtained too short Air bubbles in the cuvette Eliminate the air bubbles Clot not detected No magnetic stirrer placed Add the component missing No reagent added No sample added RESET not pressed Press RESET It does not repeat Pipetting problems Review the method and the Chronometer starts when placing the cuvette in the reading position The specified way of work was not followed material used for pipetting Press RESET again The chronometer does not start RESET was not pressed before adding the starter 8 COMPLEMENTARY INFORMATION Repeat the sample 8 1 WARRANTY bio bas 1 has one year warranty excluding all damages done by a bad use of the instrument 8 2 PC CONNECTION bio bas 1 has a RS 232 exit to be connected to a PC 8 3 ASSISTANCE Contact your local supplier 24 bio bas 1 User s manual NOTES MAINTENANCE MANUAL Period month Year LABORATORY INSTRUMENT bi as l n INSTALLED t 2 374 6 7
17. ser because it gives the result in time activity concentration RATIO and INR different parameters depending on the method 1 2 THEORY OF THE INSTRUMENT FUNCTIONING bio bas 1 has an optical measurement system which detects a sudden variation of the optical density when a clot is formed The chronometer and the stirring system are activated by a sudden change of the optical density This permits the initiation of the time measurement when the starter is added and to stop the measurement time at the moment the clot is formed The continuous mixing guarantees a perfect homogenisation and makes possible the measurement of low concentrations of Fibrinogen by grouping the fibrin filaments in the centre of the optical path The system has a programmable security time during which variations of the optical density when the reagent and the plasma are still in the homogenisation phase can not activate the detection cell 1 3 GENERAL DESCRIPTION OF THE INSTRUMENT Dimensions 16 5 x 29 x 12 8 cm Voltage and frequency 220 V 50 Hz 60 Hz Power data 100 VA bio bas 1 has the following elements Incubation zone for 10 cuvettes and one reagent Reading zone Keyboard Description of the keyboard functions bio bas 1 User s manual KEYS VAL used to display the result in Time Percentage Ratio INR concentration f increases the sample identification number decreases the sample identification number lt N changes th
18. ssing several times Y it goes to the main display 4 5 LANGUAGE It is displayed LANGUAGE 21 When pressing OK the Spanish option appears bio bas 1 User s manual SPANISH To see the other options press Y The different options are displayed ENGLISH FRENCH Press OK to accept the wanted option When pressing Y again it goes to the main display 4 6 BY DEFAULT Pressing OK to this option all introduced parameters will be removed and the original values for calibrations reference times incubation times etc will be re installed BY DEFAULT 22 5 CONSUMABLES bio bas 1 User s manual bio bas lonly requires the reagents and samples needed to run the tests and the accessories to take the samples dilute them and make the reading Reagents P T Calcium Thromboplastin physiological saline solution and control plasma P T T activator cephaline kaolin ellagic acid etc Calcium Chloride physiological saline solution and control plasma Fibrinogen Thrombine reagent buffer and calibrator Accessories Automatic micropipettes to take the required volume of sample and reagents for every method Cuvettes to read the reaction Ref FC 5200007 Magnetic stirrers to homogenise the solution Ref FC 5200008 6 MAINTENANCE A Preventive maintenance See table enclosed B Cleaning instructions When the instrument does not wo
19. t is used to present the final result as a RATIO between the sample time and the time of a normal pool of plasmas REF T 0 20 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK bio bas 1 User s manual The security time is requested It is the time during which optical variations do not stop the instrument By default is 5 SAFET 5 To modify the value use the vertical arrows 7 and to change the number use the horizontal arrow Y and confirm pressing OK The delay time is requested It is the time since RESET is pressed after placing the cuvette in the reading position till the chronometer is set to zero By default is 3 but it could be longer if the reagent presents a high turbidity DELAY 3 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK At the end the incubation time is requested In case it is programmed a value different from zero the chronometer will make a countdown to indicate the exact moment the starter should be added The minimum value that may be introduced is 30 seconds INCUB T To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK It goes to the initial display where T is displayed Pre
20. the chronometer will make a countdown to indicate the exact moment the starter should be added The minimum value that may be introduced is 30 seconds INCUB T gt To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK It goes to the initial display where PTT is displayed Pressing several times Y it goes to the main display 4 3 FIBRINOGEN From the FB display press OK to get into the configuration parameters to be modified FB Then the number of points for the calibration is requested bio bas 1 User s manual N POINTS When pressing the vertical arrows f and the number of points is increased or decreased For acceptation press OK The concentration for the first point appears CONC 400 1 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK The time defined for the first point is displayed TIME 8 1 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK The concentration for the second point is displayed CONC 200 2 To modify the value use the vertical arrows f and to change the number use the horizontal arrow Y and confirm pressing OK The time defined for the secon

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