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BFT™ II System Easy Start Guide

This guide is an education resource material designed to support routine operations, calibrations, and troubleshooting on the BFT™ II System.

HOOD05162002841760 SIEMENS Effective Date: 3/27/2018 Healthineers (Cal Esc Enter 00 Version 2018 15 ml Calcium Chloride Solution CE Incub Incub Reset Start Reset Start BFT™ II System Easy Start Guide SIEMENS BFT // Unrestricted © Siemens Healthcare GmbH, 2018 Table of Contents SIEMENS Healthineers ....... Srist Major Components 3 === Data Entry Keypad 5 Test Processing Keypad 6 Accessing the Method Parameter Menu 7 Accessing the Test Run Menu 8 Accessing the Method List Menu 9 Changing a Method Parameter 10 Running a PT Sample 11 Rese Start Hesey Start Running an aPTT Sample 12 SIEMENS BFT // Running a Fibrinogen mg/dL Sample 13 Calibrating for Fibrinogen mg/dL 14 Entering a Reference Curve for Fibrinogen mg/dL 15 2 Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Major Components 1. Display The temperature of the heating block and the selected method are displayed 2. Cuvette incubation block (37˚C) 1 STANDBY , 1ª PT 37.4 des 3X 10 positions for cuvettes 3. Reagent incubation block (37˚C) O 00 00 Four positions for reagent bottles, left position with magnetic 2 stir function 4. Two measurement channels 3 With flap guide for pipette tips 4 Incub 4 Reze Stan Rese Stan 5. Membrane keypad for function keys for test processing 5 Measuring channel, respective keys: Incub, Start, Reset Major 3 Components Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Power Supply 1. Tab to Open Fuse Holder 2 2. Fuse Holder 1 o 3. Socket with Cable 3 4. Pivot of Cover 5 5. On/Off Switch 4 Major 4 Components Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Data Entry Keypad 1. Arrow Keys: left, right < Selection according to display, backward - >. - Selection according to display, forward, set decimal point 2. Esc Key STANDBY 37.4 deg Leave parameter data entry or switch from measuring mode to PT STANDBY 4 6 3. Enter Key 1 2 3 Cal V > 1 Press to access the displayed measuring mode, advance 4 5 6 printer paper or confirm selection 2 Esc (8 9 O Enter 3 4. Numerical Keys 5 Enter parameters 5. 0 Key When the 0 key is pressed in the measuring mode, a printout of the parameters for the selected method is generated 6. Cal Key Press to enter the parameters for the measuring MODES or UTILITIES Data Entry 5 Keypad Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Test Processing Keypad 1. Incub Key Starts incubation countdown for a specific measuring channel. NOTE: If a measurement is completed before the incubation time has lapsed, the LCD will display a flashing asterisk (*) to the left of TIME until the programmed incubation time has finished. Press Incub key once to start countdown, again to stop countdown, and again to reset. 2. Reset Key Press after a completed measurement. The LCD will display “incubat./cuv out.” Press during measurement to cancel 1 measurement. The LCD will display BREAK. Incub Incub 3. Start Key 2 Rese Start Reset Star Press to start measurement manually. 3 Test 6 Processing Unrestricted © Siemens Healthcare GmbH, 2018 Keypad BFT™ II SIEMENS Healthineers Accessing the Menu: Method Parameter Secret no.: ... 1) method parameter STANDBY 37.4 deg general V > PT Cal 1) method parameter (2 (3) Cal 1 st conversion > V (4. Enter 1) method parameter (8 (9 O 2nd conversion V > 1) method parameter measurement V > Method 7 Parameter Unrestricted © Siemens Healthcare GmbH, 2018 Menu BFT™ II SIEMENS Healthineers Accessing the Menu: Test Run Incubat. Incubat. cuv in cuv in 42 s 54 s cuv in cuv in Incubat. Incubat. STANDBY 37.4 deg < 1 PT Enter Incubat. Incubat. GO 100ul GO 100ul V Cal < Incubat. Incubat. 16 Esc t= 6.2 s t= 7.4 s Enter time time t= 12.5 s t= 12.7 s INR INR 1.05 1.06 Incubat. Incubat. cuv out cuv out Test Run 8 Menu Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Accessing the Menu: Method List STANDBY 37.4 deg STANDBY 37.4 deg PT* > <2 aPTT* > STANDBY 37.4 deg STANDBY 37.4 deg <3 Thrombin Time > <4 Batroxobin Time > STANDBY 37.4 deg STANDBY 37.4 deg <5 Fib. g/l > <6 Fib. mg/dl* > STANDBY 37.4 deg PT STANDBY 37.4 deg STANDBY 37.4 deg > . <7 Extr. Factor > <8 Intr. Factor > < (3) Cal STANDBY 37.4 deg STANDBY 37.4 deg [6] < <9 PT-Innovin * <10 ProC G PCAT > V Esc 8. 9) O Enter STANDBY 37.4 deg STANDBY 37.4 deg <11 ProC G PCAT/10 > <12 ProC FV PCAT > STANDBY 37.4 deg STANDBY 37.4 deg <13 ProC FV PCAT/O > <14 none > STANDBY 37.4 deg STANDBY 37.4 deg <15 none > UTILITIES V * U.S. Approved Method List 9 Menu Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Changing a Method Parameter 1. Press >. to select aPTT as an example. STANDBY 37.4 deg < 2 aPTT 2. Press Cal and enter the secret number. 3. Press < until the second line reads . 4. Press Enter to accept. 2 method parameter Measurement > 5. Confirm or change the Start Reagent to 50 µl. 6. Press Enter. 7. Confirm or change the Lot Number. 2) Start Reag 50 lot.no. : 527338 8. Press Enter to accept. 9. The next screen shows the current incubation Actin Reagents = 180s time(s). Enter the correct incubation time(s) for your 2) incubat. (0=off) Pathromtin SL = 120s 1st= 0 s, 2nd=180 s reagent. Note: Confirm these settings 10. Press Enter to accept. 11. Enter a new starting number if you wish and press 2) printout number: start-no. 1 Enter. 12. Press Esc. 13. Confirm or cancel the new parameters. save new parameters? ENTER=yes, ESC=no 14. Press Esc to return to STANDBY. Changing a 10 Method Unrestricted © Siemens Healthcare GmbH, 2018 Parameter BFT™ II SIEMENS Healthineers Running Samples: PT 2 Place a bottle of PT reagent in one of the reagent incubation wells. incubat. incubat. Use a bottle adapter if necessary. cuv in cuv in 1. Use the >. key to cycle the LCD display to PT or PT-Innovin. 5 2. Press Enter. A new screen is displayed. 3. Pipette 50 µl of sample into the bottom of a cuvette that has been pre-warmed in the incubation block to 37˚C. 4. Press the Incub key to start the timer for the measuring channel being used. 5. After incubation, move the cuvette to the measuring channel. 6 incubat. 6. Once the “GO 100 µl” appears, pipette 100 µl of PT reagent into the GO 100 ul incubat. GO 100 ul cuvette. 7. The measuring process starts automatically. When finished an audible beep is heard. 8. Press Start to convert results and print. 9. Press Reset to clear the memory. 10. Remove the cuvette and dispose. Another sample may be processed. Running a PT 11 Sample Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Running Samples: aPTT 2 Place a bottle of aPTT reagent at the side of the analyzer and a bottle of incubat. incubat. calcium chloride in a reagent incubation well. Use a bottle adapter if cuv in cuv in necessary. 5 1. Use the >. key to cycle the LCD display to aPTT. 2. Press Enter. A new screen is displayed. 3. Pipette 50 µl of sample into the bottom of a cuvette. Then pipette 50 µl of aPTT reagent into the sample. 4. Press the Incub key to start the timer for the measuring channel being used. 5. After incubation, move the cuvette to the measuring channel. 6 incubat. GO incubat. 6. Once the “GO 50 µl” appears, pipette 50 µl of calcium chloride into the 50 ul GO 50 ul cuvette. 7. The measuring process starts automatically. When finished an audible beep is heard. 8. Press Start to convert results and print. 9. Press Reset to clear the memory. 10. Remove the cuvette and dispose. Another sample may be processed. Running an 12 aPTT Sample Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Running Samples: Fibrinogen mg/dL 2 Place a bottle of fibrinogen reagent reconstituted with kaolin suspension incubat. incubat. solution into incubation well #1. Use a bottle adapter if necessary. cuv in cuv in 1. Use the >. key to cycle the LCD display to Fib mg/dl. 5 2. Press Enter. A new screen is displayed. 3. Pipette 50 µl of sample into the bottom of a cuvette. 4. Press the Incub key to start the timer for the measuring channel being used. 5. After incubation, move the cuvette to the measuring channel. 6 7. Pipette 100 µl of Multifibren® U into the cuvette when prompted by the incubat. GO 100 ul incubat. GO 100 ul LCD display. 7. The measuring process starts automatically. When finished an audible beep is heard. 8. Press Start to convert results and print. 9. Press Reset to clear the memory. 10. Remove the cuvette and dispose. Another sample may be processed. Running a 13 Fibrinogen Unrestricted © Siemens Healthcare GmbH, 2018 Sample BFT™ II SIEMENS Healthineers Calibrating for Fibrinogen mg/dL A bottle of fibrinogen reagent which has been 1 reconstituted with kaolin suspension solution is placed in STANDBY 37.4 deg reagent position 1 (mix before use). A bottle adapter is < 6 Fib. mg/dl placed in the well, if needed, and a stir bar is added to the bottle for mixing. 10. When the Go screen appears, pipette 100 µl of 5 1. Set BFT™ II to STANDBY. 2. Press >. until Fib mg/dl is displayed. Multifibren® U into the cuvette. Repeat this process for 3. Press Enter. A new screen is displayed. the second cuvette in the right measurement channel. 4. Create a 1: 4 dilution of reconstituted Standard 3 with 11. When the coagulation analyzer time is finished for the distilled water. left channel, press Start to view the printed results. This dilution will be used as level 1. Repeat for the right channel. 5. Pipette 50 µl into the first cuvette and return cuvette to Results per channel should be very similar. incubation well. 12. Press Reset for both channels and remove cuvettes. 6. Press the left Incub key. 13. Repeat steps 5 through 12 for standards 2, 3, 4 and 5. 7. Pipette 50 µl of Standard 1 into a second cuvette and Results will be progressively longer for each remaining 9 return it to incubation well. standard. incubat. incubat. 8. Press the right Incub key. 14. When all standard results have been printed, average GO 100 ul GO 100 01 9. When a long beep is heard for the left measuring the duplicates for each standard. channel, place the cuvette into the measurement 15. Enter the average (mean) values into the BFT II as the channel and close the flap. reference curve values. NOTE: If Fib has been previously calibrated, disregard the mg/dL values reported with the seconds for the new standards. These mg/dL values are calculated from the old curve and have no *For US use only relationship with the new set of standards being tested. Calibrating for 14 Fibrinogen Unrestricted © Siemens Healthcare GmbH, 2018 BFT™ II SIEMENS Healthineers Entering Reference Curve for Fibrinogen mg/dL 1 STANDBY 37.4 deg 1. Set BFT II to STANDBY. ( 6 Fib. mg/dl 2. Press Cal and enter the secret number. 5 3. Press >. until the second line reads 1st conversion. renc Press Enter. falling 4. Press >. until the second line reads reference curve. 6 Press Enter. 5. Select Reference Curve: Falling. 6> unit: mg/dl 6. Confirm mg/dl . 7. Verify no decimal point format. 7 8. Enter the min/max values. decimal F format 9. Key in the first mg/dl value and press Enter. 8 60 min/max value: 20 /1000 mg/dl Reference 15 Curve for Unrestricted © Siemens Healthcare GmbH, 2018 Fibrinogen BFT™ II SIEMENS Healthineers Entering Reference Curve for Fibrinogen mg/dL 10. Enter the clotting time. Example: 62 1. point: 580 mg/dl 12.0 s 52 2. Point: 360 Mg/dl 18.2 s 62 3. point: 250 mg/dl 25.8 s 6) 4. Point: 110 mg/dl 67.5 s 6) 5. point: 63 mg/dl 163.2 s 6) 6. point: 0 mg/dl 0.0 s 6) time interpolat. logarithmic 11. Press Enter to confirm. Proceed with the remaining calibration points. 12 12. Enter logarithmic for the interpolation of both the 6) valueinterpolat. logarithmic time and value axes. 13. Press Esc. 14 14. Confirm or cancel the new parameters. save new parameters? 15. Press Esc to return to STANDBY. ENTER=yes, ESC=no 16. Press Enter once to begin processing samples. Reference 16 Curve for Unrestricted © Siemens Healthcare GmbH, 2018 Fibrinogen SIEMENS Healthineers Please note that the learning material is for training purposes only! For the proper use of the software or hardware, please always use the Operator Manual or Instructions for Use (hereinafter collectively “Operator Manual”) issued by Siemens Healthineers. This material is to be used as training material only and shall by no means substitute the Operator Manual. Any material used in this training will not be updated on a regular basis and does not necessarily reflect the latest version of the software and hardware available at the time of the training. The Operator's Manual shall be used as your main reference, in particular for relevant safety information like warnings and cautions. Note: Some functions shown in this material are optional and might not be part of your system. Certain products, product related claims or functionalities (hereinafter collectively “Functionality”) may not (yet) be commercially available in your country. Due to regulatory requirements, the future availability of said Functionalities in any specific country is not guaranteed. Please contact your local Siemens Healthineers sales representative for the most current information. The reproduction, transmission or distribution of this training or its contents is not permitted without express written authority. Offenders will be liable for damages. All names and data of patients, parameters and configuration dependent designations are fictional and examples only. All rights, including rights created by patent grant or registration of a utility model or design, are reserved. Copyright © Siemens Healthcare GmbH 2018 This content is for US use only. Global Siemens Healthineers Headquarters Henkestr. 127 91052 Erlangen, Germany Phone: +49 9131 84 0 siemens.com/healthineers 17 Unrestricted © Siemens Healthcare GmbH, 2018

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