Table of Contents
Summary of Contents for Drucker Diagnostics QBC STAR
- Page 1 QBC STAR System Operator’s Manual Fast, Simple CBC Analysis Designed for the Point of Care Document Number: 6000-300-000 Revision J 200 Shady Lane, Suite 170, Philipsburg, PA 16866 U.S.A. | + 1 - 814 - 692 - 7661 | www.druckerdiagnostics.com...
- Page 2 QBC STAR System Operator’s Manual The QBC STAR complies with the emission and immunity requirements described in section 9.103 of the IEC 61326 series. This equipment has been designed and tested to CISPR 11 Class A. In a domestic environment it may cause radio interference, in which case, you may need to take measures to mitigate the interference.
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Page 3: Table Of Contents
1 – Introduction ......................1–1 Intended Use ............................1–1 Principles of the Test .......................... 1–1 System Overview ..........................1–2 QBC STAR Blood Collection Tubes ..................1–2 QBC STAR Instrument ......................1–3 Instrument Self-Testing and Calibration..................... 1–4 Manual Structure ..........................1–5 Getting Started .......................... - Page 4 Key ........................... 3–4 4 – Operation ....................... 4–1 Summary of Operation Steps ......................4–1 Turn Instrument Power On ....................... 4–2 Prepare the QBC STAR Tube ....................4–2 Mix the Tube ..........................4–4 Tilt the Tube ..........................4–5 Cap the Tube ..........................4–5 Insert the Tube Into the Instrument ..................
- Page 5 Preface Contents 5 – Performance and Limitations ................5–1 Operating Ranges ..........................5–1 Precision ............................5–1 Accuracy ............................5–2 Interfering Substances ........................5–3 Limitations ............................5–4 Expected Values ..........................5–4 Controls ............................. 5–5 Internal Quality Control ......................5–5 Internal Electronic Quality Control Label .................. 5–5 External Liquid Controls ......................
- Page 6 Page QBC STAR Blood Collection Tube ..................1–2 QBC STAR Instrument ....................... 1–3 Symbols Used on the QBC STAR Instrument (rear) ............1–6 External Connections ......................2–5 QBC STAR Menu, Options ....................2-7 QBC STAR Menu, Date & Time ..................2-8 Power Switch ........................
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Page 7: Introduction
When the QBC STAR tube is filled with blood and placed into the QBC STAR instrument, the tube is spun at a high rate of speed causing the different types of cells in the blood to separate into layers or bands from the most dense to the least dense. -
Page 8: System Overview
Tubes are filled by capillary action with 65 to 75 µL of whole blood. This is the volume when the tube is filled between the 2 fill lines marked on the QBC STAR Tube. The blood can come directly from a fingerstick or from a lavender top EDTA anticoagulant only. -
Page 9: Qbc Star Instrument
Analysis of the sample occurs in the centrifuge rotor after the centrifuge is finished. A single filled QBC STAR Tube is placed into the rotor, the door is closed, and the “STAR” button pressed to start the test process. The centrifuge cycle mixes and then separates the blood into distinct cell layers. -
Page 10: Instrument Self-Testing And Calibration
32° C, but with limited reports. If the sample temperature exceeds 45° C, the unit will be- come too hot to operate. Since the QBC STAR instrument contains a centrifuge, centrifuge speed measurements are verified each time a sample is processed. -
Page 11: Manual Structure
Glossary explains several terms used in this manual, as well as abreviations. Getting Started The QBC STAR system has been designed and tested for ease of use. However, before you begin to use the instrument, you will find it advantageous to familiarize yourself with the material in this manual, especially: •... -
Page 12: Conventions
Drucker Diagnostics, or may be downloaded from the Drucker Diagnostics website (www.druckerdiagnostics.com) QBC STAR Tube Quick Reference Guide – This document contains a summary of steps for preparing venous and capillary specimens and testing them on the QBC STAR instrument. -
Page 13: Summary Of Warnings And Cautions
Do not handle the QBC STAR tube by the glass collection end of the tube. Do not use any QBC STAR tube if any part of the carrier or tube is chipped or cracked. The user should not perform any servicing except as specifically stated in this manual. Refer other problems to trained personnel, or return the instrument to Drucker Diagnostics for repair. - Page 14 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 15: Installation And Setup
Electrical Connection • Connect the female end of the power pack to the back of the QBC STAR instrument (see Figure 4). • Connect the male end of the power cord to the main AC power source. To avoid electrical shock, connect the power cord only to an approved power source such as a 3-wire grounded receptacle. -
Page 16: Qbc Star Specifications
QBC STAR System Operator’s Manual QBC STAR Specifications Physical Specifications Height (loading door open) 16.3 in (41.4 cm) Width 16 in (40.6 cm) Depth 16.3 in (41.4 cm) Weight 19 lbs (8.6 kg) Clearance 2 in (5.1 cm) Noise < 70 dB @ 3 ft... - Page 17 2 – Installation and Setup Environmental Specifications Non-Operating Storage Temperature –20 °C – 50 °C Humidity 10% – 95% non-condensing Operating 16 °C – 32 °C unrestricted ( °C at > 32 Temperature may be limited by instrument temperature shut- down or some results may be suppressed) Humidity 10% –...
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Page 18: External Connections
You can attach a keyboard, USB memory stick, barcode scanner, and a full-size external printer (for print- ing results on standard letter or A4 size paper) via the USB ports in the back of the QBC STAR instrument. You can also leave the internal instrument printer enabled even if you attach an external printer. If you do, results print on the internal printer and the external printer at the same time. -
Page 19: External Connections
How to attach an external printer: Unpack and set up the printer according to the manufacturer’s operating instructions. Connect the printer to the QBC STAR instrument’s USB port (see Figure 4). Turn on power to the QBC STAR instrument first. -
Page 20: Upgrading The Software
6. Remove USB drive from STAR and discard 7. Turn on the STAR 8. Remove printouts from step 4 and step 7 from device and mail to Drucker Diagnostics in Appendix D-1, scan a copy to qbcsupport@druckerdiagnostics.com, or fax to 814-692-7662. -
Page 21: Lcd Contrast
, the menu disappears and the cursor appears next to the item you selected. Press the 5 or 6 key to increase or decrease the value. When the desired value is shown, press . To return the original value, press ESC. Figure 6 - QBC STAR Menu, Date & Time 6000-300-000 6000-300-000... -
Page 22: Internal Printer
Printer Settings Internal Printer Internal Printer lets you enable or disable the QBC STAR system’s built-in printer. When you select the “Printer Settings” option, a sub-menu titled “Printer Settings” appears. When the printer is ENABLED, the menu lets you disable the printer by selecting option 2. You... -
Page 23: Set Language
2 – Installation and Setup Set Language Set language lets you select from the following languages: German (Deutsch); English; Spanish (Español); French (Français); Italian (Italiano). When you select the option, a sub-menu titled “LANGUAGES” appears. It lists these language selections. The arrow cursor ( ) points to the item that is currently selected. -
Page 24: Controls And Indicators
• Setup Keypad Power Switch The power switch is located on the rear panel of the QBC STAR instrument (Figure 7) on the left side. — Place the switch in the “ ” position to turn instrument power on. Place the switch in the “ ” position to turn instrument power off. -
Page 25: Star" Button
Door Release Latch The door release latch is located on the front panel of the QBC STAR instrument, just below the door. It is used to open the door on the top of the instrument. The door can only be opened when the system determines that it is safe to do so. -
Page 26: Internal Printer
3 – Controls and Indicators Internal Printer Test results print automatically at the end of the testing cycle. The printer is located on the top panel of the instrument (Figure 9). Samples of test results printouts are shown in Section 4 – Operation. See Figure 9 for printer controls. -
Page 27: Setup Keypad
QBC STAR System Operator’s Manual Setup Keypad The setup keypad is located to the front of the printer beneath the printer access panel. It is used to enter setup information into the computer, such as the date and time, LCD contrast, etc. - Page 28 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 29: Operation
IF A TUBE BREAKS IN THE UNIT, CAREFULLY REMOVE THE TUBE WITH A HE- MOSTAT OR OTHER DEVICE, USING PUNCTURE RESISTANT UTILITY GLOVES. CONTACT TECHNICAL SUPPORT FOR ADDITIONAL INFORMATION. Summary of Operation Steps Routine operation of the QBC STAR Hematology System consists of the following steps: • Turn the instrument on •... -
Page 30: Turn Instrument Power On
QBC STAR System Operator’s Manual Turn Instrument Power on Turn on the QBC STAR instrument power, by placing the power switch on the rear of the instrument — in the “ ” position. The instrument performs a self-test, which will take a few minutes. During this time, the message “System Check In Progress Please Wait”... -
Page 31: Sample Vial
Figure 11 – Sample Vial Figure 12 – Inverting the Sample Vial Open the QBC STAR Tube package by placing a fingernail between the foil seal and the molded plastic packaging, and lifting and peeling the foil layer away. For Venous Blood Samples 1. -
Page 32: Mix The Tube
For Venous and Capillary Blood Samples Fill the QBC STAR Tube between the black fill lines. Blood must always be filled to at least the first black line. This results in a blood volume of between 65 and 75 microliters. The instrument automatically detects if the fill volume is correct. -
Page 33: Tilt The Tube
4 – Operation Tilt the Tube Tilt the QBC STAR Tube as shown, and allow the blood to move down the tube toward the center of the tube. See Figure 16. Figure 16 – Tilting the Tube Cap the Tube Remove the cap from the tube by pulling it straight off. -
Page 34: Insert The Tube Into The Instrument
QBC STAR System Operator’s Manual Insert the Tube into the Instrument Insert the tube into the QBC STAR instrument oriented as shown in Figure 19. The tube must be inserted into the instrument within 15 minutes of being prepared and capped. -
Page 35: Start The Test
Rerunning Tubes The QBC STAR will process a tube that has been previously processed. To rerun a tube: Insert a STAR Tube that has already been run into the STAR. Close the Lid and press the run button. -
Page 36: Printing Of Results
QBC STAR System Operator’s Manual Printing of Results When the test is complete, the results are automatically displayed and printed. NOTE DO NOT OPEN THE INSTRUMENT DOOR UNTIL THE RESULTS ARE REVIEWED AND PRINTED. Test results are cleared from the display when the instrument door is opened. -
Page 37: Sample Results Printout
4 – Operation 4 – Operation Any errors that might occur are both displayed and printed on the results printout. Any errors that might occur are both displayed and printed on the results printout. Test results are printed when the analytical QC checks have been successful. This is indicated on the results printout as “STAR Analytical QC: Passed.” Test results are printed when the analytical QC checks have been successful. This is indicated on the results printout as “STAR Analytical QC: Passed.” A sample results printout is shown in Figure 20. A sample results readout is shown in Figure 21. -
Page 38: Tube Disposal
Tube Disposal After the results have been printed and you have reviewed the printout(s) for clarity, open the in- strument door by pressing the door release latch. Remove the QBC STAR Tube. Discard the tube in a biohazard sharps container. -
Page 39: Door Unlatch Access Hole
4 – Operation Door Latch Access Hole (Front of Instrument) (Bottom of Instrument) Figure 22 – Door Unlatch Access Hole 6000-300-000 4-11 6000-300-000 4–11... - Page 40 QBC STAR System Operator’s Manual THIS PAGE INTENTIONALLY LEFT BLANK 6000-300-000 4–12...
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Page 41: Performance And Limitations
5 – Performance and Limitations Operating Ranges Hematology parameters measured with the QBC Star system are considered valid over the following range of values: Hematocrit 15 – 65% Hemoglobin 5.0 – 20.0 g/dL Mean Corpuscular Hemoglobin Concentration 25 - 37.3 g/d Platelet Count 20 –... -
Page 42: Precision
% Lymph/Mono Precision Data on typical within-run precision tests on QBC STAR tubes tested in the QBC STAR system are shown in the two tables below. The precision data represents the analysis of eleven whole blood specimens, each assayed in replicates of 10. -
Page 43: Accuracy
In a separate precision study, intra- and inter-run precision were assessed using a dual level QBC Control (#424304). The controls were assayed on multiple days at three sites using QBC Star tubes and the QBC Star system. The results of this study are presented in the table below. -
Page 44: Interfering Substances
QBC STAR System Operator’s Manual Two QBC STAR tubes were prepared on each of approximately 323 blood samples and analyzed on both the QBC STAR system and either the Coulter STKS or Sysmex K1000 analyzers*. The correlation coefficients for the WBC, Gran, L/M, ®... -
Page 45: Limitations
The QBC STAR reagent tube has been formulated to provide optimum packing and layering of normal cells. In a small number of patients, however, the system cannot read certain parameters and will not report a value. -
Page 46: Controls
%L/M Analytical Quality Control The QBC STAR Centrifugal Hematology System has multiple built-in analytical quality control (QC) systems that maintain the overall system integrity and the quality of the test results it produces. The QBC STAR System has five analytical quality control elements: 1. -
Page 47: Maintenance
1. Overview Put the device into shipping preparation mode, per the instructions found in Section 2 of the QBC Star Operator’s Manual and power off the device. This should put the rotor into a free spinning state. Enlarged Tri-Level Quality Control Label 2. -
Page 48: Disinfection
ERS as they may damage the label finish. Disinfection If a QBC STAR Tube breaks while in the instrument, the spread of blood and glass is substantially con- tained by the plastic protective tube. This device design provides a high degree of user and instrument protection from exposure to blood and aerosols. -
Page 49: Replacing Printer Paper
It should never be used if there is surface damage to any metal parts. For any other cleaning methods, you must contact Drucker Diagnostics to verify that the proposed method does not damage the QBC STAR instrument. - Page 50 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 51: Troubleshooting
2. Unplug the AC power cord on the external power supply from the AC wall outlet. 3. Unplug the external power supply from the back of the QBC STAR. 4. Allow the external power supply and QBC STAR to sit in this condition for 15 minutes to fully discharge and reset the external power supply. -
Page 52: System Error Codes
System Error Codes From time to time, the QBC STAR may display an error code. A USB flash drive is included with the QBC STAR to download a support file of the error code (see page 2-8 for instructions on how to download the support file). - Page 53 7 – Troubleshooting 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) Centrifuge motor profile error 3. Power down the instrument (Ref. page 4-10) during Power On Self-Test (POST) 4. Reset the power pack (Ref. page 7-1) 5.
- Page 54 QBC STAR System Operator’s Manual 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) Unable to get position of the rotor 3. Power down the instrument (Ref. page 4-10) error 4. Turn the instrument Power on (Ref. page 4-2) 5.
- Page 55 7 – Troubleshooting 1. Record error message displayed on LCD screen 2. Export support file per Section 2, page 2-8 Centrifuge motor unable to position 3. Power down instrument per Section 4, page 4-10 +/- 4 steps error 4. Turn Instrument Power on per Section 4, page 4-2, if error persists contact Technical Support 1.
- Page 56 QBC STAR System Operator’s Manual 1. Record error message displayed on LCD screen Centrifuge motor low sustained 2. Export support file per Section 2, page 2-8 voltage error (Sustained voltage less 3. Power down instrument per Section 4, page 4-10 than 40 volts) 4.
- Page 57 7 – Troubleshooting E3 - Camera Board Error Number Description Corrective Action 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) Camera board error 3. Power down the instrument (Ref. page 4-10) 4.
- Page 58 QBC STAR System Operator’s Manual 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) Start-up data error 3. Power down the instrument (Ref. page 4-10) 4. Turn the instrument Power on (Ref. page 4-2) 5.
- Page 59 7 – Troubleshooting 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) 3. Pull the printer paper release lever towards the front of unit (Ref. page 3-3) 4. Manually advance the paper using the manual advance wheel Internal printer hardware error (Ref.
- Page 60 QBC STAR System Operator’s Manual 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) 3. Place the instrument into Shipping Prep (Ref. page 2-9) 4. Power down the instrument (Ref. page 4-10) 5.
- Page 61 7 – Troubleshooting E5 – File Operations Error Number Description Corrective Action 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) File operations communication 3. Power down the instrument (Ref. page 4-10) error 4.
- Page 62 QBC STAR System Operator’s Manual 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) 3. Power down the instrument (Ref. page 4-10) 4. If the lid is closed, open it manually (Ref. page 4-10) Sample door open during rotor a.
- Page 63 7 – Troubleshooting 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) Encoder failed to position properly 3. Power down the instrument (Ref. page 4-10) during Power On Self-Test (POST) 4. Turn the instrument Power on (Ref. page 4-2) 5.
- Page 64 QBC STAR System Operator’s Manual E8 – Software Error Number Description Corrective Action 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) 800 thru 802 General software errors 3. Power down the instrument (Ref. page 4-10) 4.
- Page 65 7 – Troubleshooting 1. Record the error message displayed on the LCD screen 2. Export the support file (Ref. page 2-8) Software tube check error 3. Power down the instrument (Ref. page 4-10) 4. Turn the instrument Power on (Ref. page 4-2) 5.
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Page 66: Tube Error Codes
QBC STAR System Operator’s Manual Tube Error Codes If any of the following tube error messages appear on the printer results report and LCD display, fill and run a new tube. Error Number Description Corrective Action 1. Record the error message on the LCD display 2. - Page 67 7 – Troubleshooting 1. Record the error message on the LCD display 2. Create a support file (Ref. page 2-8) 3. Open the lid and visually check the sample a. If the closure is not present, draw a new sample and retest Could not find closure b.
- Page 68 QBC STAR System Operator’s Manual 1. Record the error message on the LCD display 2. Create a support file (Ref. page 2-8) 3. Open the lid, rotate the sample 180 degrees and reinsert it into rotor Could not find Control / PLT interface 4.
- Page 69 7 – Troubleshooting 1. Record the error message on the LCD display 2. Create a support file (Ref. page 2-8) 3. Open the lid and visually check for the sample tube Tube not found a. If the sample tube is present, rotate it 180 degrees and rescan the tube b.
- Page 70 QBC STAR System Operator’s Manual 1. Record the error message on the LCD display 2. Record the age of the blood sample 3. Create a support file (Ref. page 2-8) 4. Open the lid, remove sample and stand the sample upright for...
- Page 71 7 – Troubleshooting 1. Record the error message on the LCD display 2. Create a support file (Ref. page 2-8) 3. Open the lid, rotate the sample 180 degrees and reinsert it into rotor Closure I1 is too low 4. Close the lid and rescan the sample 5.
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Page 72: Appendices
8 – Appendices 6000-300-000 6000-300-000 A–1... -
Page 73: Appendix A - Limited Warranty
QBC STAR System Operator’s Manual. Any damage to a QBC STAR system resulting from the insertion or removal of cables that connect this instrument to systems other than those approved or supplied by Drucker Diagnostics, or the failure of the owner to maintain reasonable care and precautions in the operation and maintenance of the system will void this warranty and terminate the obligations of the manufacturer as stated herein. - Page 74 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 75: Appendix B - Parts And Accessories
B – Parts and Accessories Item Catalog Number Paper, Printer (3/pk) 429580 QBC STAR Tubes (box 100) 429625 1.8 mm Blade Lancets (box 100) 420000 2.3 mm Blade Lancets (box 100) 420001 Patient ID Upgrade Keyboard 429645 Patient ID Barcode Scanner 429642 Power Cord, U.K. - Page 76 THIS PAGE INTENTIONALLY LEFT BLANK...
- Page 77 D – Contact Drucker Diagnostics 168 Bradford Dr. Port Matilda, PA 16870 USA www.druckerdiagnostics.com Phone: +1-814-692-7661 Technical Support: +1-866-265-1486 (USA only) Customer Service: +1-877-231-3115 (USA only) Fax: +1-814-692-7662 Email: Technical Service: qbcsupport@druckerdiagnostics.com Customer Service: qbccustomerservice@druckerdiagnostics.com 6000-300-000 6000-300-000 D–1...
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Page 79: Appendix C - Software Upgrade Log
C – Software Upgrade Log Whenever you receive a software upgrade, please take a moment to log it below. This can assist you and Drucker Diagnostics, personnel in identifying software revision levels, potential software problems, etc. Date Software Date Installed... - Page 80 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 81: E - Blood Collection And Handling
E – Blood Collection and Handling General Comments The quality of a test is only as good as the quality of the specimen. The following guidelines help ensure the quality of the blood specimens collected in your office, as well as the safety of the staff performing the tests. These specimen collection guidelines are derived from those recommended by the National Committee for Clinical Laboratory Standards (NCCLS) in the specimen collection section of the “Physician’s Office Laboratory Guidelines”... -
Page 82: Venous Blood Collection (Venipuncture
QBC STAR System Operator’s/Service Manual Venous Blood Collection (Venipuncture) The following procedure can be used as a guideline for venous blood collection. Please consult your lab’s standard operating procedure as it may differ from the procedure described below. Supplies •... -
Page 83: Collecting Multiple Specimens From A Single Venipuncture
E – Blood Collection and Handling As the blood begins to flow into the tube, release the tourniquet and open the patient’s fist to avoid bleeding at the puncture site. Keep constant, forward pressure on the tube to prevent the shutoff valve from closing and stopping the flow of blood. -
Page 84: Errors To Avoid In Venous Blood Collection
Fill the QBC STAR Tube by placing the collection end of the tube directly in contact with the finger puncture blood. Fill the QBC STAR Tube to a level between the two black fill lines. -
Page 85: Avoiding Hemolysis During Capillary Blood Collection
E – Blood Collection and Handling 10 Dispose of lancet(s) in a sharps container. Dispose of gloves and gauze in an appropriate biological hazard container. Wash hands. Avoiding Hemolysis during Capillary Blood Collection • Allow the puncture site to dry after cleaning with alcohol. •... - Page 86 THIS PAGE INTENTIONALLY LEFT BLANK...
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Page 87: F – Bibliography
F – Bibliography Wintrobe, M.M. (1933) “Macroscopic Examination of the Blood,” American Journal of Medicine, SC., 185:58-71. Olef, I. (1937) “The Determination of Platelet Volume,” Journal of Laboratory and Clinical Medicine, 23:166-178. Bessis, M. (1940) “Une méthode permettant L’isolement des différents éléments figurés du sang,” Sang 14:262. - Page 88 G – Glossary Complete Blood Count g’s Unit of acceleration, 1g = acceleration of gravity Gran Granulocytes Hemoglobin Hematocrit Lymphocytes and Monocytes Lymph/Monos Lymphocytes and Monocytes MCHC Mean Corpuscular Hemoglobin Concentration Platelets Revolutions per minute White blood cell count 6000-300-000 6000-300-000 G–1...
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