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BD FACSPresto™ Near-Patient CD4 Counter 651000 Instructions For Use 23-12808-02 11/2014 Becton, Dickinson and Company Becton Dickinson Pty Ltd, BD Biosciences 4 Research Park Drive, Macquarie University Research Park, 2350 Qume Drive North Ryde NSW 2113, Australia San Jose, CA 95131 USA...
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BD Biosciences. The information in this guide is subject to change without notice. BD Biosciences reserves the right to change its products and services at any time to incorporate the latest technological developments. Although this guide has been prepared with every precaution to ensure accuracy, BD Biosciences assumes no liability for any errors or omissions, nor for any damages resulting from the application or use of this information.
Introduction This chapter covers the following topics: • Product documentation (page 6) • Technical assistance (page 7) • Safety symbols used in this guide (page 8)
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Product documentation This topic describes the available documentation for the Introduction BD FACSPresto™ Near-Patient CD4 Counter (the instrument) and other system components. All users should read this information. Documents • BD FACSPresto Near-Patient CD4 Counter Instructions For Use (IFU).
Technical assistance This topic describes how to get technical assistance. Introduction Contacting If assistance is required, contact your local BD Biosciences technical support technical support representative or supplier. Visit our website, bdbiosciences.com, for up-to-date contact information. When contacting BD Biosciences, have the following information available: •...
Although these symbols appear in color on the instrument, they might be printed in black and white; their meaning remains unchanged. • See the BD FACSPresto Near-Patient CD4 Counter Safety and More information Limitations Guide for safety information and symbol...
BD FACSPresto Near-Patient CD4 Counter Instructions For Use About the system Introduction This topic describes how the BD FACSPresto system works. Intended use The BD FACSPresto Near-Patient CD4 Counter is an automated system for in vitro diagnostic use in performing the direct...
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• Sheer Plastic Bandages, Sterile, Hypoallergenic, Non- latex • BD FACSPresto Instrument Carrying Case • BD FACSPresto Solar Charge Kit (includes solar panel, solar generator, and power supply) • BD FACSPresto Solar Generator (includes solar generator and power supply) •...
BD FACSPresto Near-Patient CD4 Counter Instructions For Use • BD FACSPresto Cartridge IFU System components Introduction This topic describes the BD FACSPresto system components. Before operating the system, you should familiarize yourself with the names, locations, and functions of the various system components.
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Chapter 2: System overview Component Description Touchscreen Display for operating the instrument. Power button Button used to turn the instrument on or off. Cartridge Door that automatically opens when you need door to insert or remove the cartridge. Do not manually open the cartridge door.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Power, service, and identification components are located on the Instrument rear view rear of the instrument. Component Description Lift handle Handle used to move the instrument. Air vent Enables air flow into and out of the instrument.
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Chapter 2: System overview BD FACSPresto The BD FACSPresto cartridge, the CD4/%CD4/Hb cartridge, is a unit-dose disposable device that contains all the reagents that are cartridge needed to test one sample or specimen. Use one cartridge per specimen. Use only BD FACSPresto cartridges with the instrument.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use 10 11 Component Description Covers the inlet port and acts as a biohazard- containment mechanism. Inlet port Receives blood or process control into the cartridge using the pipet or finger stick method.
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BD FACSPresto The BD FACSPresto work station can hold up to 10 cartridges work station during incubation. The slots are numbered. Place the cartridge in the slot as shown in the following figure. You can monitor the...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Component Description Tube or pen holders Hold tubes or pens. Handle Handle used to hold and carry the work station. Cartridge BD FACSPresto cartridge. Cartridge slot Slot used to hold a cartridge.
Chapter 2: System overview Software overview This topic describes the software for the BD FACSPresto Introduction instrument and how to use it. About the Press the tabs and buttons on the touchscreen to use the software. touchscreen Avoid using sharp objects on the screen because they can damage the screen.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Tab name or Icon Description Settings Use to set the date, time, display brightness, volume, Hb units, lab name, operator names, and process control information. Help Use to view instructional videos. Battery charge...
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Chapter 2: System overview Keyboard A keyboard opens when your input is needed. An example of the keyboard used for entering the patient ID is shown in the following figure. Button Patient ID Backspace Caps Lock Accept...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Navigation buttons The following table describes the basic buttons in the software. Button Description Increases the setting in a field (for example, setting the date). Decreases the setting in a field (for example, setting the time).
2. Remove the instrument from the plastic bag. Keep the instrument packaging. Use the packaging to pack the instrument in case you need to return it to BD Biosciences for service. 3. Place the instrument on a level surface, a minimum of 1.27 cm (0.5 in.) away from the wall.
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Chapter 3: Instrument setup Power connection The following figure shows the power connection using a wall electrical outlet. using a wall electrical outlet Component Power supply Adapter cord Power connection To connect power to the instrument using a car battery charge using a car battery adapter: charge adapter...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use 3. Plug the car charge battery adapter into the instrument. Component LED light Do not use the instrument in a car with a running engine. Note: You can also use the car charge battery adapter to charge the solar generator.
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Chapter 3: Instrument setup The solar panel needs 11–22 hours to fully charge the solar generator, depending on the sun. Component Solar panel Solar generator 2. Plug the solar generator into the instrument.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use When not in use, plug the solar generator into a wall electrical outlet or other electric source. This ensures that the solar generator is charged for the next use. Power connection The solar generator can be used without the solar panel, as another using a solar power supply.
Chapter 3: Instrument setup Instrument Turn the instrument off when it is not in use. If the instrument is running on battery power only and not in use for 35 minutes, it shutdown automatically shuts down. You should turn the instrument off at least one time per day.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use The following figure shows the screen with the Settings tab Settings tab selected. Button Date Time Display brightness Volume Hb Units Lab Name Operator Quality Control...
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Chapter 3: Instrument setup Setting the display To set up the instrument display: 1. Press the Settings tab. 2. Press a button to change one of the following settings: • Date (year/month/day) • Time • Display brightness • Volume, from high to mute •...
Instrument use This chapter covers the following topics: • Setting the on-board timer (page 34) • Watching the instructional videos (page 36) • Upgrading the software (page 38)
Incubate each cartridge for at least 18 minutes, but no longer than 2 hours. About the on-board Use the on-board timer while the cartridge is in the BD FACSPresto work station. There are 10 timers, one for each cartridge slot in the timer work station.
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1. Press the On-board Timer tab. 2. Press the timer that corresponds to the numbered slot containing the cartridge on the BD FACSPresto work station. The timer starts at 18 minutes and shows the minutes and seconds remaining until incubation is complete. It turns green when complete.
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Watching the instructional videos Introduction This topic describes how to watch the instructional videos from the Help tab. The videos provide training on workflow tasks. The following figure shows the Help tab’s video selection screen.
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Chapter 4: Instrument use Component Description Settings Video on setting the date, time, display brightness, volume, Hb unit, lab name, operator names, and process control information. Software version Software version installed on the instrument. Date Date of software version. Delete All Button for deleting all test results.
BD FACSPresto Near-Patient CD4 Counter Instructions For Use To watch the instructional videos: Procedure 1. Press the Help tab. 2. Select a video in the video selection screen. The selected video starts playing. 3. Press Pause, Fast Forward, Rewind, Stop, or Play to control the video.
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Chapter 4: Instrument use The software upgrade screen opens. Component Software version on the USB flash drive Current software version on the instrument Back Accept If you do not want to upgrade the software on the instrument, press Back. The Welcome screen opens and the current software version starts.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use The software upgrade proceeds. When the software upgrade completes, the following screen opens. Component Upgraded software version on instrument Remove the USB flash drive Accept 5. Remove the USB flash drive. 6. Press Accept.
Quality and process control This chapter covers the following topics: • Quality and process control overview (page 42) • Running instrument QC (page 44) • Entering process control information (page 45) • Preparing process controls (page 50) • Running process controls (page 53)
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Quality and process control overview Introduction This topic provides information on running instrument quality control (QC) and process controls. Instrument QC is a test to make sure that your instrument is About instrument operating properly.
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From the QC tab, you can run instrument QC, and CD4 and Hb process controls. Button Instrument QC CD4 Process Control Hb Process Control More information • To run QC manually, see Running instrument QC (page 44). • BD FACSPresto Cartridge IFU...
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Running instrument QC Introduction This topic describes how to manually run instrument QC. Procedure To run instrument QC: 1. Press the QC tab. 2. Press Instrument QC. Button or field Instrument QC Date instrument QC was last performed The Instrument QC Operator screen opens.
Chapter 5: Quality and process control 3. Select your operator ID and press Accept. Button Operators Back Accept A progress screen opens. When instrument QC is complete, the instrument beeps 3 times, a results screen opens, and the results automatically print. 4.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use See the documentation that came with your process controls for the lot number, expiration date, and range values. Process Control The following figure shows the screen with the QC button in the Settings tab selected.
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Chapter 5: Quality and process control The CD4PC Low Settings screen opens. Field or Button Lower Limit CD4 Count Lower Limit CD4 Percentage Back Lot Number Backspace Accept Upper Limit CD4 Count Upper Limit CD4 Percentage Expiration Date 4. Press the Lower Limit CD4 Count field on the left and enter a value (according to the process control documentation) with up to four digits with no decimal places.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use 7. Press the Upper Limit CD4 Percentage field on the right and enter a value. 8. Press the Lot Number field and enter the lot number for the process control (1–10 characters).
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Chapter 5: Quality and process control The HbPC Level 1 Settings Screen opens. Field or Button Lower Limit HbPC Concentration Upper Limit HbPC Concentration Expiration Date Accept Back Lot Number Backspace 2. Press the Lower Limit HbPC Concentration field and enter a value (according to the process control documentation) with up to three digits including one decimal place.
BD FACSPresto Near-Patient CD4 Counter Instructions For Use 6. Press the Expiration Date field and press Up or Down to set the year, month, and day. 7. Press Accept. The Expiration Date screen closes. 8. Press Accept on the HbPC L1 Settings screen to save all the entered data for the Hb Level 1 process control.
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Chapter 5: Quality and process control Procedure Perform this procedure for the CD4 low count, CD4 normal count, CD4 percentage, Hb low concentration, Hb normal concentration, and Hb high concentration. To prepare process controls: 1. Carefully dispense the process control into the inlet port of the cartridge.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use 4. Set the on-board timer. See Setting the on-board timer (page 34). 5. Make sure the fill indicator is full. Some process controls might be difficult to see in the cartridge. Check the fill indicator carefully.
Chapter 5: Quality and process control Running process controls This topic describes how to run process controls. Introduction Process Control The following figure shows the screen with process control results. Results screen Field or button Instrument QC Result Cartridge QC Result Accept Process Control Results To run process controls:...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use The CD4 Process Control Selection screen opens. Field or Button Process Control Low Back Expiration date for process controls Date of last process control run Lot number for process controls Process Control Normal 3.
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Chapter 5: Quality and process control 7. Remove the ejected cartridge within 30 seconds. If you do not remove the cartridge within 30 seconds, the cartridge goes back into the instrument. If this happens, press Open door and remove the ejected cartridge. The CD4 Process Control Selection screen opens.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use • Running samples (page 64) • Troubleshooting (page 76)
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Sample processing overview Introduction This topic describes the workflow for preparing a capillary or venipuncture blood sample using the cartridge and instrument. The workflow for sample processing includes the following stages. Workflow...
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Chapter 6: Sample processing Before you begin • Open the alcohol pad package. • Remove the cover on the lancet. • Open the bandage package. • Open the cartridge package. Write the patient ID on the cartridge. Face the inlet port up. You must use the cartridge within 30 minutes of opening the package.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use The initial drop might contain tissue fluids that may dilute the sample. 7. Wait until a large drop of blood forms. 8. Apply the blood to the inlet port of the cartridge.
13. Place the cartridge, barcode side up, on the work station. Running samples (page 64) Next step More information • BD FACSPresto work station (page 17) • BD FACSPresto cartridge (page 15) Preparing a venipuncture blood sample This topic describes how to add a previously collected Introduction venipuncture blood specimen into the cartridge.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Open the cartridge package. Write the patient ID on the cartridge. Before you begin Face the inlet port up. You must use the cartridge within 30 minutes of opening the package. Procedure To prepare a venipuncture sample: 1.
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8. Make sure the fill indicator is full. 9. Place the cartridge, barcode side up, on the work station. Running samples (page 64) Next step More information • BD FACSPresto work station (page 17) • BD FACSPresto cartridge (page 15)
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Running samples Introduction This topic describes how to run samples from the Run Test tab. You cannot start a run if the instrument has a low battery. You cannot turn off the instrument during a run.
Chapter 6: Sample processing Inserting the cartridge This topic describes how to insert the cartridge into the instrument. Introduction Procedure To insert the cartridge: 1. Select your Operator ID and press Accept. Button Back Operator ID Accept The cartridge door on the instrument opens. Note: If possible, complete the following two steps within 30 seconds.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use 2. Remove the channel protector from the cartridge. Do not touch the cartridge except for the closed cap. 3. Hold the cap with the channel facing upwards. Insert the prepared cartridge into the cartridge door, as shown in the following figure.
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Chapter 6: Sample processing The sample is processed and a progress screen opens. Typically, a sample takes 4 minutes to process.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use When the process is complete, the instrument beeps 3 times, the results appear on the screen, and automatically print. Description Product and software version Results type. Patient results are shown in this example. Other result types are process controls, and instrument QC.
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Chapter 6: Sample processing Description Date and time of test Operator Cartridge lot number Cartridge expiration date Instrument QC result Cartridge QC result Patient number CD4 absolute count Hemoglobin concentration CD4 percentage of lymphocytes Note: For process control results, the process control lot number and process control expiration date are also listed in the results.
BD FACSPresto Near-Patient CD4 Counter Instructions For Use • BD FACSPresto Near-Patient CD4 Counter Safety and Limitations Guide Managing test results Introduction This topic describes how to search, filter, print, delete, and export test results. Press the Results tab to manage the test results.
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Chapter 6: Sample processing Searching for test To search for test results: results 1. Press Up or Down to scroll through the test results. Filtering test You can filter test results by patient ID, date, or both. To filter test results results by both patient ID and date, perform both of the following procedures.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use To print a test result: 1. Select a test result. 2. Press Print. Deleting test Before you delete a test result, you should export it to a USB flash drive. You should delete all test results from the instrument before results sending the instrument to BD Biosciences for service.
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Chapter 6: Sample processing Exporting test The instrument can store up to 12,000 results in its internal memory. Results include sample runs, QC runs, and process results control runs. If the instrument exceeds 12,000 results, it deletes the oldest result. To back up your results, export them to a USB flash drive.
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Troubleshooting Introduction This topic describes how to troubleshoot problems with the instrument. Error screens alert you to issues with the hardware, software, and cartridge. If additional assistance is required, contact your local BD Biosciences technical support representative or...
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Chapter 7: Instrument reference Errors The following table describes possible errors and recommended solutions. Note the error code on the screen. For technical support, BD Biosciences might ask for this code. Error displayed Possible causes Recommended solutions A critical failure 1.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Error displayed Possible causes Recommended solutions The printer does Contact BD Biosciences. not respond and requires service. The battery does Contact BD Biosciences. not charge and requires service. The sample or 1. Wait 2 minutes.
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Chapter 7: Instrument reference Error displayed Possible causes Recommended solutions The instrument 1. Make sure the channel cannot read the protector is removed from barcode or the cartridge. channel. 2. Clean the barcode label or channel. 3. Re-insert the cartridge into the instrument.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Error displayed Possible causes Recommended solutions Results are not If the error code is 6B16 or shown. 6102: 1. Re-run instrument QC. 2. Insert the cartridge into the instrument again. If you get the same error screens, prepare a new cartridge.
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2. Press the power button to turn on the instrument. 3. If the error persists, contact BD Biosciences. The instrument 1. Make sure the air vents temperature is are unobstructed. outside its 2. Press the power button...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Error displayed Possible causes Recommended solutions The instrument 1. Make sure the air vents temperature is are unobstructed. outside its 2. Wait for the instrument to operational return to its operational range, and will range.
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The USB flash Insert the USB flash drive into drive is full. a PC and remove some files. Insert another BD USB flash drive into the USB port. The USB flash Insert another BD USB flash drive is not drive into the USB port.
BD FACSPresto Near-Patient CD4 Counter Instructions For Use Maintenance, transportation, and disposal Introduction This topic describes the maintenance procedures that should be performed on the instrument and work station when necessary. It also describes how to transport and how to dispose of the instrument.
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Chapter 7: Instrument reference Changing the To change the printer paper: printer paper 1. Lift the printer door latch. Component Printer door latch. Button to eject paper from printer. Green light means the printer is ready to print. Red light means the printer is out of paper or the printer door is open.
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use 4. Insert the new paper roll into the printer, as shown in the following figure. Component Paper roll Printer door 5. Close the printer door. Caution: Mechanical! Use caution when opening or closing the printer door.
Chapter 7: Instrument reference Disposing of the Separate collection of waste at the end of life as required by European Directives. Dispose of in accordance with the applicable instrument country regulation. More information • Instrument shutdown (page 29) • Technical assistance (page 7) •...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use Item Description Temperature at ≤2,500 meters above sea level Operating and Storage Operating: 10°C–40°C (50°F–104°F) Environment Storage: 0°C–50°C (32°F–122°F) Humidity: 10%–95% non-condensing Vibration: Do not operate the instrument near a running vortexer, centrifuge, or microcentrifuge.
Chapter 7: Instrument reference Power requirements This topic describes the power requirements necessary for the Introduction instrument to operate uninterrupted in any location worldwide. Requirements The instrument uses battery or electrical power. The power supply connects the instrument and adapter cord. Frequency Voltage requirements Region...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use deleting test results 72 cleaning 84 depth, instrument 87 cover 84 display 13, 31 disposal 87 display brightness setting 29 heat dissipation 88 disposing of the instrument 87 lab name 29 lift handle 14...
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Index power, instrument 87 preparing a capillary blood sample 58 lab name 29 preparing a venipuncture sample 61 lancet 10, 58, 59 preparing process controls 50 lift handle 14 preparing samples 58 printer 13 paper, changing 85 maintenance printing test results 71 changing the printer paper 85 process control 45 cleaning the instrument or work...
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BD FACSPresto Near-Patient CD4 Counter Instructions For Use running samples 64 tabs 19 Help 20 On-board Timer 19 Safety and Limitations 6 Quality Control (QC) 19 safety symbols 8 Results 19 sample collection video 36 Run Test 19 sample processing 58...
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Index volume setting 29 weight, instrument 87 width, instrument 87 work station 17, 84...
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