bio bas. 2 USER S MANUAL

Transcription

1 Ctra. Santa Coloma, 7. E-17176, Sant Esteve de Bas. Girona. Spain. Tel Fax bio bas. 2 USER S MANUAL

2 INDEX 1. INTRODUCTION INSTALLATION STARTING 7 4. SAMPLES PERFORMANCES Practic Procedure Prothrombin Time (P.T.) Activated Partial Thromboplastin Time (APTT) Fibrinogen (FB) Time (T) NEW METHOD PROGRAMMING Prothrombin Time or Quick Test (P.T.) Activated Partial Thromboplastin Time (APTT) Fibrinogen concentration (FB) Time (T) AVAILABLE FUNCTIONS MAINTENANCE COMPLEMENTARY INFORMATION 40 NOTES 41 MANUAL MAINTENANCE Rev. 0 2

3 1. INTRODUCTION The automatic coagulometer bio bas.2 B is a two channel instrument for the determination of the main parameters used in the plasma coagulation methods: Prothrombin Time or Quick test (PT) Activated Partial Thromboplastin Time (APTT) Trombine Time (TT) Fibrinogen Concentration (FB) Moreover the instrument can be used for other determinations like Factor deficiency studies. Theoric principe: bio bas.2 coagulometer has an optical measuring system that detects the variation of optical density when the clot is formed. The chronometer and the homogenisation system are activated when a sudden variation of optical density is produced, which permits to start the time counting when the sample contacts the reagent, and also to stop when the clot is formed. The constant mixing guaranties a perfect homogenisation and makes easier the Fibrinogen concentration measurement at low concentrations when the fibrin filaments are grouped in the optical path. The system has a programmable security time during which the optical density variations that occurs when the reagent and plasma are in the homogenisation time, do not stop the chronometer. Precaution actions and cares: The installation and handling of bio bas.2 does not imply any risk and the only precaution to be taken is the use of a plug with good earth connection. bio bas.2 does not require special handling, apart from a correct use that must be given to all precision instruments. Rev. 0 3

4 Main components: bio bas.2 has the following elements: Incubation zone for 21 sample positions for cuvettes and two for reagents. 2 reading positions. Keyboard.. Printer. Keyboard functions description: KEYS: 1-9: numerical entry of data. 0 corresponds to YES and 1 corresponds to NO. PRINT: help or data printing. ENTER: data confirmation. RESET (1 and 2): zero set for the chronometer or exit from the working program. FEED: paper feed. CL: delete the data that are between brackets in the display. */ID: decimal point and identification. STOP: exit from working program. Symbols: In this manual a series of abbreviations appear which correspond to the following methods and parameters: PT: Prothrombin Time or Quick Test APTT: Activated Partial Thromboplastin Time FB: Fibrinogen Concentration T: Time A: Activity CONC.: Concentration ISI: International Standarditation Index RATIO: Quotient of the measured time and reference time (with 100% of activity). INR: International Normalyzed Ratio Reagents: P.T.: Calcium Thromboplastin and physiological saline solution. P.T.T.: activator (cephaline-caolin, ellagic acid, etc...), calcium chloride and physiological saline solution. Fibrinogen: Thrombin reagent and buffer. Rev. 0 4

5 Accessories: Automatic micropipettes: to take de sample and reagents volumes required for every method. Cuvettes: to take place the reaction. Ref: FC Magnetic stirrers: to homogenise the solutio. Ref: FC Roll paper: Ref: DDX Functioning criteria and limitations: The instrument has an accuracy of 1 tenth of second. Regarding precision, due to the fact that it is a manual instrument, the influence of pipetting and the reagents state is very important and to obtain a good repeatability with the results the indications of the producer and the same working method. Technical specifications: Dimensions: 31 x 34.5 x 14.5 cm. Weight: 5 Kg. Voltage: 220 V - 50 Hz, 60 Hz Power: 100 VA Rev. 0 5

6 2. INSTALLATION bio bas.2 should be stored in a dry place without extreme temperatures. During the unpacking it should be checked if the instrument and the accessories are in a perfect state. The accessories that should accompany the Clot 2 B are: 2 fuses of 2 amperes 1 printer paper roll 1 plastic cover 1 user manual 1 connection cable 2 caps 50 coagulation cuvettes 50 stirring bars In case you detect any aberration inform your distributor as soon as possible and complete the corresponding reception form, enclosed in the box. Preparation previous to installation: a) Conditions of the instalment place: bio bas.2 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 be between 15 and 35 ºC without excessive humidity. b) Technical requirements: The connection to the electrical net should be made with the included connection cable and only if earth connection exists. Rev. 0 6

7 3. STARTING bio bas.2 User s manual When switching bio bas.2, it automatically makes a check, the message bio bas.2 is displayed and the main menu appears: CODE ( ) CLOT 2B 37 1 PT 2 PTT 3 FB 4 T In the lower part of the display all programmed methods (from 1 to 10) are shown. The number that appears on the right corner is the temperature (37ºC) and if it is flashing means the thermostat has not reached 37º C yet. To know the available functions, press PRINT and they are printed: 100: New methods edition. 101: Activate and deactivate the printer. 102: Methods printing. 103: Modify methods. 104: Language change. 105: Date and time change. 106: Mode. List of programming methods up to 10. bio bas.2 16/7/2001 AVAL. FUNCUTIONS EDIT MODE 101.PRINTING ON/OFF 102.PRINTING METHODS 103.MODIF. MODE 104.LANGUAGE 105.DATE 106.MODE 1. PTT 2. PT 3. FB 4. T Printing of available functions. If it is wanted to go to a previous programmed method, press the corresponding code number (from 1 to 10) that appears in the previous display. If a new method is wanted to be programmed, press option 100 to edit methods. Rev. 0 7

8 4. SAMPLES PERFORMANCES bio bas.2 User s manual 4.1. PRACTIC PROCEDURE: Place the reaction cuvettes in the thermostat and introduce the magnetic stirrers, one into each. Wait for the instrument to be at 37ºC. Dispense in the cuvettes the required volume of reagent or sample ( volumes for Gernon reagents) PT: Quick Time. Pipette 200 µl of reagent. PTT: Activated Partial Thromboplastin Time. Pipette 100 µl of reagent and 100 µl of plasma. Fibrinogen: Pipette 200 µl of diluted plasma. It is very important to avoid bubble formation, due to the fact that the instrument could detect them and stop before the clot formation. 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 is added and PIPETTE IN A COMPLETE VERTICAL POSITION when adding the plasma or 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 it 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 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. Add 100 μl of the starter: PT - Plasma PTT - Calcium Chloride Fibrinogen - Thrombin reagent The addition MUST be done with a disposable tip pipette. DO NOT USE piston pipettes nor the glass one, because the liquid falls drop by drop, not with 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 Rev. 0 8

9 wanted to use, 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 appears on the display. 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 follow the incubation standardisation, it is possible to work with plasmas at room temperature (20 25 ºC), after taking the reference at the same temperature. INTERNAL QUALITY CONTROL Results validation: it is recommended the use of normal and pathological control plasmas normal and pathological to check the mean value is repeated every day. 4.2 PROTHROMBIN TIME (P.T.): From the main menu tape the code number corresponding to a PT program followed by ENTER. It is printed: /7/01 COD: 1 PT N. POINTS: 2 T ACT ISI:2 SAFE T.:5 DELAY:3 INCUB.T.:0 Then, on the display the option for calibration appears: CALIBRATE (Y/N) Rev. 0 9

10 If the answer is negative, it directly goes to the samples measurements Method calibration: There are two calibration methods: a) By entering the coagulation time directly from keyboard. b) By entering the times measured by the coagulometer at that moment. a) Introduction directly from keyboard: the times corresponding to the different points of the calibration curve will appear if they were already introduced when the method was programmed (in this case 12 seconds for 100% activity). To change it, introduce the new time and press ENTER (for example, 11.6 ENTER). POINTS: 1 A%: ( 100 ) TIME: ( 12 ) POINTS: 1 A%: ( 100 ) TIME: ( 11.6 ) This operation is repeated for the second point, introducing first the activity in percentage (e.g., 25 ENTER, if dilution is 1:4). POINTS: 2 A%: ( 25 ) TIME: Initial display for 2 nd point Then, the time is introduced. (e.g., 18.9 and ENTER). The values introduced in the programming (25% and 18 seconds) appear on the respective fields to be modified. POINTS: 2 A%: ( 25 ) TIME: ( 18 ) POINTS: 2 A%: ( 25 ) TIME: ( 18.9 ) After pressing the last ENTER it goes to the display that informs about the sample identification number to be run (1 appears by default). It can be modified if ID is pressed followed by a new number and validated by ENTER. The new calibration data are printed out. Rev. 0 10

11 /7/01 COD: 1 PT N. POINTS: 2 T ACT ISI:2 SAFE T.:5 DELAY:3 INCUB. T.:0 The instrument is ready to run samples. b) Calibration by measurements: After answering affirmatively to the question if a calibration is wanted, on the display the 100% activity appears and the corresponding time, if it was previously programmed (in this case, 12 seconds), which now can be modified: POINTS: 1 A%: ( 100 ) TIME: ( 12 ) The cuvette, previously incubated, is placed in the measuring position. Press RESET, the chronometer appears on the display and it is set to (000:0) after the delay (---:-). The stirring system and the chronometer are activated when the last component is added. When the clot is formed (fibrin polymerisation) there is a positive variation in optical density that stops the chronometer and the stirring system. POINTS: 1 A%: 100 TIME: ( 12 ) 0:000 POINTS: 1 A%: 100 TIME: ( 12 ) 11:20 If RESET is pressed twice, the chronometer is ready for another measurement. It is recommended to repeat the measurement before validating the result. Pressing ENTER, the measured time is accepted (e.g.11.2 seconds). Rev. 0 11

12 POINTS: 1 A%: 100 TIME: ( 11.2 ) Pressing any key, the chronometer is deleted and any time can be entered from keyboard. Pressing ENTER once again, it goes to the second point of the calibration curve. Here it is possible to modify the activity value, introducing it from the keyboard and validating it by ENTER. For instance, 25% of activity. POINTS: 2 A%: ( 25 ) TIME: Proceed following the same procedure as for the first point pressing RESET 1 for the chronometer to be displayed. POINTS: 2 A%: 25 TIME: ( 18 ) 0:000 PPOINTS: 2 A%: 25 TIME: ( 18 ) 18:90 Pressing two times more RESET 1, the chronometer is ready to repeat the following point for calibration. It is recommended to repeat the measurement before validating the result. Pressing ENTER, the measured time is accepted (e.g s.) POINTS: 1 A%: 100 TIME: ( 18.9 ) Pressing any numeric key, the chronometer is deleted and if it is wanted the time value can be introduced by keyboard. If the chronometer is set to zero, it can only be eliminated by pressing STOP. When the time measurement is finished, and ENTER is pressed again, the method with the calibration values is printed, and it shows the display that informs about the sample number to be run (1 appears by default). Rev. 0 12

13 /7/01 COD 1 PT N. POINTS: 2 T ACT ID1 1 ID2 1 ISI:2 SAFE T.: 5 DELAY: 3 INCUB.T.: 0 Method impression Samples measurements: Samples identification: Samples are identified depending on the measuring channel (C1 or C2 in paper and ID1 or ID2 on display) and by reading order (ID followed by a number). If the sample number is wanted to be modified, press ID and tape the new identification. The successive samples will be identified by correlative numbers. When pressing ID, it is possible to modify the samples identification of channel 1. Tape the wanted value and press ENTER. ID1 ( 1 ) ID2 1 Then, it is possible to modify the samples identification of channel 2. Tape the wanted value and press ENTER. ID1 1 ID2( 1 ) If the incubation time has been programmed (e.g.: 300 seconds): the chronometer is displayed by pressing RESET 1 or RESET 2 and it is activated by pressing RESET again; starting the countdown. ID1 1 ID :0 Rev. 0 13

14 When there are 20 seconds left to finish the countdown, the message Put tube is displayed followed by a bip. ID1 1 ID2 1 Put tube 000:0 When the countdown is finished, the chronometer is inactivated during the delay time and then it is set to zero (000:0). If the incubation time has not been programmed, it appear on the display: ID1 1 ID2 1 When pressing RESET 1 or RESET 2 and after having placed the cuvette in the reading position, the chronometer sets to zero (000:0) after the delay time (---:-). ID 1 1 ID :0 When the plasma is added, the chronometer and the homogenisation system start. When the clot formation starts (fibrin polymerisation) there is a positive variation of the optical density that automatically stops the chronometer and the magnetic mixing system. The report is displayed and printed out C1 ID:1 ID.: 1 TIME: 12.6 ACT.: 92 RATIO: 1.08 INR: 1.17 T: 12 A%: 92 RAT: 1.08 INR: 1.17 ID2 1 Results printing Results are showed as time, percentage of activity, RATIO (ratio between the sample time and the one obtained when measuring the 100% activity in the calibration curve) and INR (International Normalised Ratio) which is the ratio elevated to ISI (International Sensitivity Index of Thromboplastin). The ID is also shown. To measure a new sample, place another cuvette, previously incubated, in the reading position. To modify the identification, proceed as described into Samples identification. Rev. 0 14

15 When RESET is pressed again, the chronometer is set to zero (000:0) and the coagulometer is ready for the new measurement. Press STOP to exit ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT): From the main menu tape the code number corresponding to and APTT program, followed by ENTER. It is printed: /7/01 COD.: 2 PTT REF. T.:30 SAFE T.: 5 DELAY: 3 INCUB.T.:0 Method printing If the reference time is not programmed, it goes to the display that shows the sample number to be run (1 appears by default). ID1 ID Method calibration: If the reference time is programmed, it is asked if calibration is wanted. CALIBRATE (Y/N) If the answer is negative, it means that the programmed one is accepted. If the answer is positive, it can be modified by taping the wanted value and ENTER. REF.T. ( 30 ) Or doing the different measurements of the different points to be used in the calibration, with the instrument. Rev. 0 15

16 Pressing RESET 1, the chronometer appears, and it sets to 000:0 after the delay time. Make the measurement with a pool of normal plasmas. REF. T..: ( ) 000:0 REF. T.: ( ) 32:0 If RESET is pressed twice, the chronometer is ready for another measurement. It is recommended to repeat the measurements before validating the results. Pressing ENTER, the measured time is accepted (e.g. 32 seconds). Pressing any numeric key, the chronometer is deleted and any time can be entered from keyboard. If the chronometer is set to zero, it can only be eliminated by pressing STOP. By pressing ENTER, the method is printed out /7/01 COD.:2 PTT REF. T.: 32 SAFE T.: 5 DELAY: 3 INCUB.T.:0 ID1 1 ID2 1 ID.: 1 TIME: 30 RATIO: 0.98 Results printing Samples measurements: Samples identification: Samples are identified depending on the measuring channel (C1 or C2 in paper and ID1 or ID2 on display) and by reading order (ID followed by a number). If the sample number is wanted to be modified, press ID and tape the new identification. The successive samples will be identified by correlative numbers. When pressing ID, it is possible to modify the samples identification of channel 1. Tape the wanted value and press ENTER. ID1 ( 1 ) ID2 1 Rev. 0 16

17 Then, it is possible to modify the samples identification of channel 2. Tape the wanted value and press ENTER. ID1 1 ID2( 1 ) If the incubation time has been programmed (e.g. 300 seconds), the chronometer is displayed by pressing RESET 1 or RESET 2 and it is activated when pressing RESET again; starting the countdown. ID1 1 ID :0 300:0 ID1 1 ID2 1 Put tube 300:0 020:0 When there are 20 seconds left to finish the countdown, the message Put tube is displayed followed by a bip. When the countdown is finished, the chronometer is inactive during the delay time and then it is set to zero (000:0). If the incubation time has not been programmed, it appear on the display: ID1 1 ID2 1 When pressing RESET 1 or RESET 2 and after having placed the cuvette in the reading position, the chronometer sets to zero (000:0) after the delay time (---:-). ID1 1 ID :0 When the calcium chloride is added, the chronometer and the homogenisation system start. When the clot is formed (fibrin polymerisation) there is a positive variation of the optical density that automatically stops the chronometer and the magnetic mixing system. The result is obtained as time and if a reference time has been programmed, it is also expressed as RATIO between the measured time and the reference one. The ID is also indicated. The reopst is displayed and printed out: Rev. 0 17

18 /7/01 COD.:2 PTT REF. T..: 32 SAFE T.: 5 DELAY: 3 INCUB. T.:0 ID2 1 T: 30 RAT: 0.94 C1 ID.: 1 TIME: 30 RATIO: 0.94 Printing results To measure a new sample, place another new cuvette, previously incubated, in the reading position. To modify the identification, procced as described into Samples identification. When RESET is pressed again, the chronometer is set to zero (000:0) and the coagulometer is ready for the new measurement. If the incubation time was programmed, proceed as described before. Press STOP to exit FIBRINOGEN: From the main menu tape the code number corresponding to a Fibrinogen program, followed by ENTER. It is printed: /7/01 COD.: 3 FB N. PPOINTS: 3 T CONC SAFE T.: 5 DELAY: 3 INCUB.T.: 0 Then, on the display the option for calibration appears: Rev. 0 18

19 CALIBRATE (Y/N) If the answer is negative, it directly goes to the samples measurements Method Calibration: There are two calibration methods: a) By entering the coagulation time directly from keyboard. b) By entering the times measured by the coagulometer at that moment. a) Introduction directly from keyboard: tape the concentration value and the coagulation time and validate it by ENTER. (e.g., 450 and 8.9 seconds). In the first screen it appears the concentration value if it was previously introduced by programming. POINTS: 1 CONC.: ( 500 ) POINTS: 1 CONC.: ( 450 ) TIME: POINTS: 1 CONC.: ( 450 ) TIME: ( 8.9 ) TIME: This procedure is repeated as many times as points have been programmed, and every time appear the same sequence of screens, varying the point number. Once the introduction is finished. the method with the new validated points is printed out. After pressing the last ENTER, it goes to the display that informs about the number of samples to be run (1 appears by default). The programmed method is printed. Rev. 0 19

20 /7/01 COD.: 3 FB N. POINTS: 3 T CONC SAFE T.: 5 DELAY: 3 INCUB.T.: 0 Printing methods It can be modified by pressing the ID key taping the wanted number and ENTER. b) Calibration by measurements: If there was a value for the concentration and time, pressing ENTER they are validated. If not, enter the concentration value for the first point and proceed to measure the coagulation time. POINTS: 1 CONC.: ( 500 ) TIME: for the 1 st point Place the cuvette previously thermostated in the reading position of the channel 1, press RESET 1 and the chronometer set to zero 000:0 appears after the delay time. When the reagent is added, the chronometer and the mixing start. When the clot is formed (fibrin polymerisation) there is a positive variation of optical density that automatically stops the chronometer and the mixing system. If the Fibrinogen concentration is very low, the optical density variations can be negative and in that case the clot is also detected. The result of the time measuring is displayed (e.g., 8.40). POINTS 1 CONC. 500 TIME ( 8.9 ) 8:40 If RESET is pressed twice, the chronometer is ready for another calibration point measurement. It is recommended to repeat the measurement before validating the results. Pressing ENTER, the measured time is accepted (e.g., 8.4 seconds). Rev. 0 20

21 Pressing any numeric key, the chronometer is deleted and the time can be entered from keyboard. If the chronometer is set to zero, it can only be eliminated by pressing STOP. Pressing ENTER it goes to the next point screen: POINTS: 2 CONC ( 200 ) TIME: If there was a value for the concentration and the time, pressing ENTER they are validated. If not, enter the concentration value for the first point and proceed to measure the coagulation time. Then it goes to the display where the time field is activated: POINTS: 2 CONC.: ( 200 ) TIME: ( 14.1 ) POINTS: 2 CONC.: ( 200 ) TIME: ( 14.1 ) 000:0 If there was a previous value for the time, it will appear between brackets, (it can be validated by ENTER). When pressing RESET, the chronometer appears and it is activated by adding the reagent that activates the coagulation. When the clot is formed, the chronometer stops, obtaining a time, e.g seconds. POINTS: 2 CONC ( 200 ) TIME: ( 14.1 ) 13.9 If ENTER is pressed twice, the chronometer is ready for another calibration point measurement. It is recommended to repeat the measurement before validating the results. Pressing ENTER, the measured time is accepted (e.g., 13.9 seconds). Pressing any numeric key, the chronometer is deleted and the time can be entered from keyboard. If the chronometer is set to zero, it can only be eliminated by pressing STOP. By pressing ENTER it goes to the third point screen and proceed as in the previous two points. When the reading of this last point is done, the method is printed: Rev. 0 21

22 /7/01 COD.: 3 FB N. POINTS: 3 T CONC SAFE T.: 5 DELAY: 3 INCUB.T.: Samples measurements: Samples identification: Samples are identified depending on the measuring channel (C1 or C2 in paper and ID1 or ID2 on display) and by reading order (ID followed by a number). If the sample number is wanted to be modified, press ID and tape the new identification. The successive samples will be identified by correlative numbers. When pressing ID, it is possible to modify the samples identification of channel 1. Tape the wanted value and press ENTER. ID1 ( 1 ) ID2 1 Then, it is possible to modify the samples identification of channel 2. Tape the wanted value and press ENTER. ID1 1 ID2( 1 ) If the incubation time has been programmed (e.g. 30 seconds), the chronometer is displayed by pressing RESET 1 or RESET 2 and it is activated by pressing RESET 1 or RESET 2 again; starting the countdown. ID1 1 ID 2 1 Put tube 020:0 When there are 20 seconds left to finish the countdown, the message Put tube is displayed followed by a bip. Rev. 0 22

23 When the countdown is finished, the chronometer is inactive during the delay time and then it is set to zero (000:0). If the incubation time has not been programmed, it appear on the display: ID1 1 ID2 1 When pressing RESET 1 or RESET 2 and after having placed the cuvette in the reading position, the chronometer sets to zero (000:0) after the delay time (---:-). When the reagent is added, the chronometer and the homogenisation system starts. When the clot is formed (fibrin polymerisation) there is a positive variation of the optical density that automatically stops the chronometer and the magnetic mixing system. The result is reported as time and if a reference time has been programmed, it is also expressed as RATIO between the measured time and the reference one.the ID is also indicated. The report is displayed and printed out: /7/01 COD.:3 FB N. POINTS: 3 T CONC T: 9.2 ID2 1 CON: 370 C1 ID:1 TIME: 9.6 CONC.: 410 C2 ID:1 TIME: 8.6 CONC.: 433 Printing display To measure a new sample, place another cuvette, previously incubated, in the reading position. To modify the identification, proceed as described into Samples identification. When RESET is pressed again, the chronometer is set to zero (000:0) and the coagulometer is ready for a new measurement. Repeat this measuring process and the result is displayed and printed: Rev. 0 23

24 /7/01 COD.:3 FB N. POINTS: 3 T CONC bio bas.2 User s manual T: 9:6 I.D.2 1 CONC: :0 1 st reading C1 ID:1 TIME: 9.6 CONC.: 410 C2 ID:2 TIME: 9.9 CONC.: 360 T:9.6 CONC: T:9.9 CONC: Printing results 2 nd reading Press STOP to exit TIME: From the main menu tape the code number corresponding to a Time program, followed ENTER. It is printed out: /7/01 COD.:4 T REF. T.:0 SAFE T.:5 DELAY:3 INCUB.T.:0 Printing Then, on the display the option for calibration appears CALIBRATE (Y/N) If the answer is negative, it directly goes to the samples measurements. Rev. 0 24

25 If the reference time has been programmed, it directly goes to the display where the samples identification to be run is indicated (1 appears by default). This value can be changed pressing the ID key and then taping the wanted value. ID1 1 ID Method Calibration: There are two calibration methods: a) By entering the coagulation time directly from keyboard. b) By entering the times measured by the coagulometer at that moment. a) Introduction directly from keyboard: tape the reference time value and validate it by ENTER, e.g. 20 ENTER. Before taping the reference value, the one previously programmed is displayed /7/01 COD.4: T REF. T.: 18.5 SAFE T.: 5 DELAY: 3 INCUB.T.: 0 Method printing b) Time measurements from instrument: place the cuvette in the reading position of channel 1, press RESET 1 and the chronometer appears. After the delay time is set to zero 000:0. REF. T.. (20) 000:0 The starter reagent or plasma is added and the instrument stops when the clot formation starts. REF. T. (20) 18:50 Rev. 0 25

26 The measured time is registered in the chronometer. If RESET is pressed twice, the chronometer is ready for another time measurement. It is recommended to repeat the measurement before validating the result. Pressing ENTER the measured time is accepted (e.g., 18.5 seconds). Pressing STOP, the chronometer is deleted and the time value can be introduced by keyboard. Pressing ENTER, the method is printed with the new reference time value /7/01 COD.4: T REF.T..: 18.5 SAFE T.: 5 DELAY: 3 INCUB.T.: 0 Method printing ID1 1 ID Samples measurements: If the incubation time has been programmed (e.g. 30 seconds), the chronometer is displayed by pressing RESET 1 or RESET 2 and it is activated by pressing RESET again; starting the countdown. ID1 1 ID :0 When there are 20 seconds left to finish the countdown, the message Put tube is displayed, followed by a bip. ID1 1 ID 2 1 Put tube 020:0 ID 2 1 Rev. 0 26

27 When the countdown is finished, the chronometer is inactive during the delay time and then it is set to zero (000:0). If the incubation time was not programmed when RESET1 or RESET 2 after having placed the cuvette in the reading position, the chronometer is set to zero (000:0) after the delay (---:-). ID1 1 ID :0 When the reagent is added, the chronometer and the homogenisation system starts. When the clot is formed (fibrin polymerisation) there is a positive variation of the optical density that automatically stops the chronometer and the magnetic mixing system. The result is obtained as time and if a reference time has been programmed, it is also expressed as RATIO between the measured time and the reference one.the ID is also indicated. The report is displayed and printed out: /7/01 COD.4: T REF. T.: 0 SAFE T.: 5 DELAY: 3 INCUB.T.: 0 C1 ID:1 TIME: 24.5 C2 ID:1 TIME: /7/01 COD.4: T REF. T.: 20 SAFE T.: 5 DELAY: 3 INCUB.T.: 0 C1 ID:1 TIME: 24.5 RATIO: 1.22 C2 ID:1 TIME: 26.0 RATIO: 1.3 ID1 1 ID :5 026:0 Rev. 0 27

28 5. NEW METHOD PROGRAMMING bio bas.2 User s manual From the main menu press 100 followed by the code number (1-10) which corresponds to the position in the memory where the new method will be stored. CODE: ( 100 ) CLOT 2B 1 PT 2 PTT 3 FB 4 T CODE: ( ) If this position is already occupied, it appears on the display: POSITION OCCUPIED EDIT Y/N? When the answer is affirmative (Y): the MODE options will appear and the previous programmed method will be cancelled. When the answer is negative (N): it will return to the main menu. If this position is not occupied, when ENTER is pressed, the MODE options will appear on the display and the number corresponding to the wanted method must be pressed: MODE ( ) 0 PT 2 FB 1 PTT 3 T Dislay 5.1. PROTHROMBIN TIME OR QUICK TEST (P.T.): After choosing option 0 in the mode field, the number of points to be used for the calibration curve must be indicated. By default 2 is displayed. N. POINTS ( 2 ) The program selects the 100% of activity for the first point. The second point should be near to the 25 % of activity, that means a 1:4 dilution of a pool of plasmas or of a normal calibrator plasma. Tape the number of points followed by ENTER. It is displayed: Rev. 0 28

29 POINTS: 1 A%: 100 TIME: ( ) The time of the 100% activity is entered from the keyboard, if it has been previously determined (for example, 12 and ENTER). To introduce the measured data when doing the test with the coagulometer, press ENTER. POINTS: 1 A%: 100 TIME: ( 12 ) Then the following point appears on the display: POINTS: 2 A%: ( ) TIME: The percentage of activity of this point should be entered, followed by ENTER. POINTS: 2 A%: ( 25 ) TIME: ( ) To introduce the time previously determinate using the keyboard tape it followed by ENTER. To introduce the measured data when performing the test with the coagulometer, press ENTER: POINTS: 2 A%: ( 25 ) TIME: ( 18 ) Rev. 0 29

30 Finally, the following four parameters must be introduced, from the keyboard after pressing ENTER: 1. I.S.I.: this is the International Standardisation Index, provided by the reagent manufacturer and it must be always introduced. ISI: ( ) 2. Security time: during this time, optical density variations can not stop the chronometer. It is programmed for 5 seconds, although it can be changed from the keyboard. SAFE T.: ( 5 ) 3. Delay: it is the minimum time that passes, after pressing ENTER, when the cuvette is already placed in the reading position, until the last component is added. It is programmed for 3 seconds but it can be modified to be longer if the reagent has a high turbidity. DELAY: ( 3 ) 4. Incubation time: optional use. In case of programming, the coagulometer makes a countdown until the moment the last component must be added. The minimum incubation time that can be programmed is 30 seconds. If this parameter is not wanted to be used, press 0 and ENTER. INCUB.T.: ( ) After pressing ENTER, the method is programmed and printed and the main menu appears again on the display : Rev. 0 30

31 CODE ( ) CLOT 37 1 PT 2 PTT 3 FB 4 T /7/01 COD 1 PT N. POINTS: 2 T ACT ISI:2 SAFE T.: 5 DELAY: 3 INCUB.T.: 0 Method printing 5.2. ACTIVATED PARTIAL THROMBOPLASTIN TIME (APTT): After choosing option 1 in the mode field, the following parameters must be introduced, followed by ENTER. 1. Reference time: optional programming. It can be used for expressing the final result as a RATIO between the sample time and the calibrator time or the normal plasma pool time. If this parameter is not wanted press 0 ENTER. REFER. T.: ( ) 2. Security time: during this time, optical density variations can not stop the chronometer. It is programmed for 5 seconds, although it can be changed from the keyboard SAFE T.: ( 5 ) 3. Delay: it is the minimum time that passes after pressing ENTER, when the cuvette is already placed in the reading position, until the last component is added. It is programmed for 3 seconds but it can be modified to be longer if the reagent has a high turbidity. DELAY: ( 3 ) Rev. 0 31

32 4. Incubation time: optional use. In case of programming, the coagulometer makes a countdown until the moment the last component is added. The minimum incubation time that can be programmed is 30 seconds. If this parameter is not wanted, press 0 and ENTER. INCUBA. T.: ( ) After pressing ENTER, the method is programmed and printed and the main menu appears again on the display: CODE ( ) CLOT 2B 37 1 PT 2 PTT 3 FB 4 T /7/01 COD.: 2 PTT REF. T.:30 SAFE T.: 5 DELAY: 3 INCUB.T.:0 Method printing 5.3. FIBRINOGEN CONCENTRATION (FB): After choosing option 2 in the mode field, the number of points to be used for the calibration curve must be indicated. By default 2 is displayed. N. POINTS: ( 2 ) The use of 3 points is recommended for a correct calibration curve, although it is possible to work with a 2 points curve. Sample dilutions must be prepared with the buffer solutions supplied by the reagent manufacturer and the dilutions must be 1:10 or lower (for example, 1:10, 1:20 and 1:30). Introduce every point with its clotting time, doing as follows. For the first point this display apears: Rev. 0 32

33 POINTS: 1 CONC: ( ) TIME: Introduce the concentration value can the time if known from keyboard and followed by ENTER. In case experimental values are preferred to be introduced, just tape the concentration values for each point and press ENTER. POINTS: 1 CONC: ( 400 ) TIME: ( ) For the next points the following displays appear: POINTS: 2 CONC: ( ) TIME: POINTS: 3 CONC: ( ) TIME: POINTS: 2 CONC: ( 300 ) TIME: ( ) POINTS: 3 CONC: ( 200 ) TIME: ( ) Proceed as above entering the concentration and time values if known. In case experimental values are preferred to be introduced, just tape the concentration values for each point and press ENTER. Then introduced the following parameters, followed by ENTER. 1. Security time: during this time, optical density variations can not stop the instrument. It is programmed for 5 seconds, although it can be changed by keyboard. SAFE T.: ( 5 ) Rev. 0 33

34 2. Delay: it is the minimum time that passes, after pressing ENTER when the cuvette is already placed in the reading position, until the last component is added. It is programmed for 3 seconds but it can be modify to be longer if the reagent has a high turbidity. DELAY: ( 3 ) 3. Incubation time: optional use. In case of programming, the coagulometer makes a countdown until the moment last component is added. The minimum incubation time that can be programmed is 30 seconds. If this parameter is not wanted, press 0 ENTER. INCUB.T.: ( ) After pressing ENTER, the method is programmed and printed and the main menu appears again on the display: CODE ( ) CLOT 2B 37 1 PT 2 PTT 3 FB 4 T /7/01 COD.: 3 FB N. POINTS: 3 T CONC SAFE T.: 5 DELAY: 3 INCUB.T.: 0 Method printing 5.4. TIME (T): After choosing option 3 in the mode field, the following parameters must be introduced, followed by ENTER. 1. Reference time: optional programming. It can be used for the expression of the final result as a RATIO between the sample time and the calibrator time or the normal plasma pool time. If this parameter is not wanted, press 0 and ENTER. Rev. 0 34

35 REFER. T.: ( ) 2. Security time: during this time, optical density variations can not stop the chronometer. It is programmed for 5 seconds, although it can be changed from the keyboard. SAFE T.: ( 5 ) 3. Delay: it is the minimum time that passes after pressing ENTER, when the cuvette is already placed in the reading position, until the last component is added. It is programmed for 3 seconds but it can be modified to be longer if the reagent has a high turbidity. DELAY: ( 3 ) 4. Incubation time: optional use. In case of programming, the coagulometer makes a countdown until the moment the last component is added. The minimum incubation time that can be programmed is 30 seconds. If this parameter is not wanted, press 0 and ENTER. INCUB.T.: ( ) After pressing ENTER, the method is programmed and printed and the main menu appears again on the display: CODE ( ) CLOT 2B 37 1 PT 2 PTT 3 FB 4 T /7/01 COD.:4 T REF. T.: 0 SAFE T.: 5 DELAY: 3 INCUB.T: 0 Method printing Rev. 0 35

36 6. AVAILABLE FUNCTIONS Apart from the programmed methods, it is possible to access to the available functions pressing PRINT: 100: Edit mode 101: Activate and deactivate the printer 102: Print methods 103: Modify methods 104: Change language 105: Change date and time 106. Mode List of methods programmed, up to 10. Printer activation When code 101 is taped, the printer is activated or deactivated and it is indicated on the display: PRINTER ON PRINTER OFF Print methods When 102 is taped, the wished programmed method (or methods) is printed. Introduce the code number of the method on the display where it appears: FROM: ( ) TO: ( ) From: the first method to be printed. To: the last method to be printed. Modify methods When 103 is taped, it is possible to enter the code of the method to be modified, followed by ENTER. Then, all parameters are displayed and can be changed if needed, by pressing ENTER every time. Once finished, the method is printed out. Rev. 0 36

37 Language change bio bas.2 User s manual When 104 is taped, the following displays appear, depending on the working language. Select the number corresponding to the chosen language and press ENTER. LANGUAGE ( ) 0. SPANISH 1. ENGLISH 2. FRENCH For instance, to change from English to Spanish, press 0 followed by ENTER. Switch off the instrument off and after some seconds switch it on again. From now on the instrument works with the latest selected language IDIOMA ( ) 0. CASTELLANO 1. INGLES 2. FRANCES LANGUE ( ) 0. ESPAGNOL 1. ANGLAIS 2. FRANÇAIS Date and Time change When 105 is taped, the date and time of the instrument can be changed: 16/07/ :13:42 CHANGE DATE? If a change is wanted, press the Y key. On the display the different fields will appear empty to introduce the correct values, followed by ENTER. If the original value are wanted to be left, just press ENTER. DD(16) MM YY HH MM SS Mode When 106 is taped, it is possible the instrument to give the results one by one (NORMAL) or doing the mean value of two consecutive measurements (DUPLICATE). If normal mode is chosen, results are given one by one as indicated in the previous sections of this manual. Rev. 0 37

38 If duplicate mode is chosen, the instrument gives the mean value of two consecutive readings. This information is only printed out, not displayed. MEAN ID:1 TIME: 12.1 ACT.: 94.5 RATIO: 0.96 INR: 0.91 Rev. 0 38

39 7. MAINTENANCE Instructions for cleaning and maintenance: When the instrument is switched off, it must be protected with the plastic cover to avoid dirty, specially in the reading position. This cover must be placed some minutes after the instrument is switched off (when it is cool). It is also important to try to not pipette reagents into the reading well if the cuvette is not placed in the reading zone. It is recommended to have fuses in stock. Problems and solutions: PROBLEMS MOTIVES SOLUTIONS Time too short Air bubbles in the cuvette Air bubble elimination The clot has not been detected There is no stirring bar There is no reagent There is no sample RESET has not been pressed Add the missing component Press RESET No repeatability Troubles with pipetting Inspect method and material The chronometer is activated when the cuvette is placed in the measurement position Chronometer does not activate Deleted method in the main menu Indications for the measurement have not been followed RESET has not been pressed before the last reagent addition Programming not finished of a new method for pipetting Press RESET again Test again The method needs a new programming Rev. 0 39

40 8. COMPLEMENTARY INFORMATION bio bas.2 User s manual WARRANTY: bio bas.2 instrument has a warranty period of one year, excluding the damage produced by a bad use. It has an RS 232 exit to connect the instrument to a computer. (A 3 meters cable is requested.) For any assistance, contact your distributor. Rev. 0 40

41 NOTES Rev. 0 41

42 MAINTENANCE MANUAL Period month: Year: LABORATORY INSTRUMENT: bio bas.2 Nº: INSTALLED: DAILY CONTROL Read a control. MONTHLY CONTROL Read a high control. Read a low control. ANNUAL CONTROL Clean the optical groups. Read a high control. Read a low control. Operator TAS NOTES

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