CoaguSense Coag-Sense Professional Users Manual
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CoaguSense Coag-Sense Professional Users Manual

Prothrombin time (pt) /inr monitoring system
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Coag-Sense
Prothrombin Time (PT)/INR
Monitoring System
Professional User's Manual

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Mikel Johnson
March 27, 2025

Trying new batch of cartridges, No barcode reader on our monitor. " barcode read failure.

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1 comments:
Mr. Anderson
March 27, 2025

If there is a barcode read failure and no barcode reader on the monitor, manually enter the strip information into the touchscreen to perform the test.

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Summary of Contents for CoaguSense Coag-Sense

  • Page 1 ™ Coag-Sense Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual...
  • Page 2 CoaguSense. Coag-Sense is a trademark of CoaguSense, Inc.

  • Page 3: Contacting Coagusense

    Contacting CoaguSense Contacting CoaguSense If you have any questions or concerns with the Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System, please contact CoaguSense Technical Support at: CoaguSense, Inc. 48377 Fremont Blvd., STE. 113 Fremont, CA 94538 Toll Free: 1-866-903-0890 E-Mail: techsupport@coagusense.com Note ◙: The Coag-Sense Prothrombin Time (PT)/INR Monitoring...
  • Page 4 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual The Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Intended Use The Coag-Sense Prothrombin Time (PT)/INR Monitoring System is an in vitro diagnostic device that provides quantitative prothrombin time (PT) results, expressed in seconds and INR units.
  • Page 5 Contacting CoaguSense is too low, the risk of blood clots increases. If the INR is too high, the risk of hemorrhaging increases. The patient’s physician will determine the most appropriate INR range for the patient, depending upon the patient’s indication and how they respond to the oral anticoagulant.

  • Page 6: Table Of Contents

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Table of Contents Contacting CoaguSense ............3 Table of Contents ............... 6 1. About This Manual ............7 2. System Description ............8 3. Reordering Information ..........12 4. Warnings and Precautions ..........12 5.

  • Page 7: About This Manual

    The purpose of the Coag-Sense Prothrombin Time (PT)/INR Monitoring System User Manual is to help you understand your Coag-Sense PT/INR system, its parts, and its intended function. It provides you with the information you need to perform a PT test with the Coag-Sense PT/INR system.

  • Page 8: System Description

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 2. System Description The Coag-Sense Prothrombin Time (PT)/INR System is used for quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Coag-Sense PT/INR system is intended for use outside the body (in vitro diagnostic use) to test patients taking warfarin-type oral anticoagulant (blood thinning) therapy who need to monitor clotting time.
  • Page 9 System Description Your Coag-Sense PT/INR Professional System (Catalog number 03P60-01) comes supplied with:  Coag-Sense PT/INR Meter  Coag-Sense PT/INR System Professional User’s Manual  Coag-Sense PT/INR System Professional Quick Reference Guide  Four AA 1.5 V Alkaline Batteries (not installed) ...
  • Page 10 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual The Coag-Sense Meter: Top View Meter Display Menu Power Buttons On/Off Button Strip Holder The Coag-Sense Meter: Bottom View Battery Door Battery Door Release Page 10 For In Vitro Diagnostic Use...
  • Page 11 System Description The Coag-Sense Meter: Rear View Data Adapter Port Jack The Coag-Sense Test Strip Mixing Wheel and Reaction Well Sample Application Handle Area Bar Code (Green light flashing when (Faces down when ready for sample) inserted into meter) CoaguSense, Inc.

  • Page 12: Reordering Information

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 3. Reordering Information For a description of the products listed below, please see the information above. Product Catalog # Coag-Sense PT/INR Professional System 03P60-01 Coag-Sense Test Strip Kit, Box of 50...
  • Page 13 The Coag-Sense PT/INR system is for in vitro diagnostic use only.  The Coag-Sense meter will not produce a result if the test strip is past its expiration date  The quality of the blood sample can affect PT test results.
  • Page 14 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual is completely dry. If any alcohol remains (or is re- introduced) on the finger, it may cause unreliable results.  The quality of fingerstick and the sample delivery technique are important to the test results. If there is...
  • Page 15 Do not move or touch the meter while it is running a test. Unreliable results may occur.  Store and use the Coag-Sense PT/INR system following the instructions in this manual.  This equipment is tested to meet the limits for medical...
  • Page 16 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual using the optional AC power adapter, the display screen may go blank. If this occurs, unplug the power supply from the back of your meter, wait 5 seconds and plug it back in.

  • Page 17: Hazards And Symbols

    For In vitro diagnostic use Storage temperature range Manufacturer Single Use Only – Do Not Reuse This product meets the provisions of Council Directive 98/79/EC for In Vitro Diagnostic Devices Authorized/European Representative CoaguSense, Inc. For In Vitro Diagnostic Use Page 17...

  • Page 18: Directions For Use

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Directions for Use Note ◙: The Coag-Sense PT/INR system is packaged in a special box. Do not discard this box. Re-use the package to transport the meter or, if directed by Customer Service to return it for testing.

  • Page 19: Power On And Off

    The blinking characters Press NEXT to advance may be changed by to next character. pressing + to increase or – to decrease. When correct, press NEXT to advance to the next character. CoaguSense, Inc. For In Vitro Diagnostic Use Page 19...
  • Page 20 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Action Meter Display Once you have entered the correct date and time, 12:00PM press DONE to exit this 1/01/10 function. Once the date and time DONE NEXT are set, the display looks like this.

  • Page 21: Performing A Control Test

    WARNING: Do not move or touch the meter while it is running a test. Unreliable results may occur. Note ◙: If an error message appears, consult the “Troubleshooting” section of this manual. CoaguSense, Inc. For In Vitro Diagnostic Use Page 21...
  • Page 22 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Action Meter Display READY 1. Make sure that the power is on by pressing the POWER INSERT button on the top of the STRIP meter and the display looks like this.
  • Page 23 Press the plunger then insert the tip of the MiniPipette into the solution. Slowly release the pressure on the plunger allowing the MiniPipette tip to fill with control activation CoaguSense, Inc. For In Vitro Diagnostic Use Page 23...
  • Page 24 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Action Meter Display solution. Note ◙: Be careful to avoid getting bubbles in the pipette tip. Right after collecting the control strip activation solution, place the tip of the pipette at a 45º angle into...
  • Page 25 If you are not going to test, turn off the meter by pressing the POWER button. The opened control activation solution may be used until the expiration date. CoaguSense, Inc. For In Vitro Diagnostic Use Page 25...

  • Page 26: Performing A Pt Test

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 10. Performing a PT Test WARNING: Place the meter on a stationary, level surface for testing. Do not move the meter or allow it to vibrate during a test. Unreliable results may occur. Wear gloves and follow all applicable hygiene and safety procedures.
  • Page 27 6. When the warm-up is APPLY complete, the meter SAMPLE beeps once. The screen looks like this. Note ◙: You now have 2 STOP minutes to apply the sample to the test strip. CoaguSense, Inc. For In Vitro Diagnostic Use Page 27...
  • Page 28 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Action Meter Display 7. Right after collecting the patient sample, place the tip of the MiniPipette at a 45º angle into the sample well on the test strip where you see the flashing green light.
  • Page 29 If left unattended, the meter automatically turns off in a few minutes. The last 100 test results are stored in memory with the time and date. Refer to “Reviewing the Memory” in this manual for more information. CoaguSense, Inc. For In Vitro Diagnostic Use Page 29...
  • Page 30 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual WARNING: Unexpected results An unexpected result may include any result that falls outside the patient’s therapeutic target range, or a result that falls inside the target range but is not consistent with the patient’s current health status (e.g., patient is experiencing bleeding or...

  • Page 31: Collecting A Fingerstick Sample

    Good circulation can be seen if the patient’s fingertip changes to a pinkish shade.  Use a 21g 1.8 mm depth single-use auto-disabling lancet. Smaller gauge/shallow depth lancets (i.e. CoaguSense, Inc. For In Vitro Diagnostic Use Page 31...
  • Page 32 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual diabetes 23g lancets) should not be used. Refer to the Lancet device instructions for more information on use.  Lance the fleshy part of the fingertip just slightly left or right of the center. Press lancet firmly against finger.
  • Page 33 Dry the fingertip with gauze to remove any excess alcohol. Place the patient’s on solid surface with the palm of the hand facing up. CoaguSense, Inc. For In Vitro Diagnostic Use Page 33...
  • Page 34 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Action Meter Display Remove the cap from the single use lancet. Place it against the skin. Holding the body of the lancet, push down firmly against the finger to lance the surface of skin.
  • Page 35 Apply gauze to the patient’s fingerstick site with firm pressure until the bleeding stops. Apply a bandage if desired. 10. Throw the lancet and the strip into a SHARPS container. CoaguSense, Inc. For In Vitro Diagnostic Use Page 35...

  • Page 36: Sample Collection And Transfer Methods

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Sample Collection and Transfer Methods MiniPipette Use this procedure to apply a capillary whole blood sample or control activation solution to the strip using the MiniPipette. Firmly attach a pipette tip to the end of the MiniPipette.
  • Page 37 Note ◙: If you release the plunger while the tip is still in the sample well, it could remove some of the sample from the well. This could lead to a short sampling error. CoaguSense, Inc. For In Vitro Diagnostic Use Page 37...
  • Page 38 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Sample Transfer Tubes In place of the MiniPipette, you may use the Sample Transfer Tubes included with each box of Coag-Sense test strips. When ready to collect the drop of blood, hold the...
  • Page 39 Note ◙: If you release the tube while the tip is still in the sample well, it could remove some of the sample from the well. This could lead to short sampling related errors. CoaguSense, Inc. For In Vitro Diagnostic Use Page 39...

  • Page 40: Reviewing The Memory

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 12. Reviewing the Memory The Coag-Sense meter stores up to 100 results along with the date and time, in its memory. When the 100th result is reached, the first result 1 is replaced (written over) with test results for test number 101.

  • Page 41: Printing

    Sample Collection and Transfer Methods 13. Printing With the optional portable printer and cable results from the Coag-Sense meter memory can be printed on either thermal paper or other media such as thermal labels for applying to patient charts. What you’ll need: ...
  • Page 42 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Printing Test Results: 1. Attach the Null Modem Adapter to the data port on the back of the Coag-Sense Meter. Connect the large DB9 end of the Citizen printer cable to the Null Modem Adapter.

  • Page 43: Control Strips

    Quality control is an important part of PT time testing. Using the high and low control strips ensures you are performing the steps of the test correctly. It also ensures that your Coag-Sense System is working properly and that test strips were not subjected to temperature extremes during shipment.
  • Page 44 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual The AA 1.5 V batteries will last for approximately 300 tests if the meter is operating only on batteries. The batteries may last through their shelf life if the optional AC power adapter is plugged in.
  • Page 45 4 new standard 1.5V AA alkaline batteries. (The proper direction for battery placement is shown on a figure inside the battery compartment). Replace the battery door. Properly dispose of old batteries. CoaguSense, Inc. For In Vitro Diagnostic Use Page 45...

  • Page 46: Cleaning And Disinfecting The Meter

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 16. Cleaning and Disinfecting the Meter No maintenance is required other than routine cleaning and/or disinfecting. To clean the outside of the meter use a clean damp non-abrasive cloth. If instructions for use are properly followed, patients should not...
  • Page 47 One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025 .htm “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.htm CoaguSense, Inc. For In Vitro Diagnostic Use Page 47...

  • Page 48: Troubleshooting

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 17. Troubleshooting You may see the following error messages while using the Coag- Sense meter. This section discusses how to resolve most problems that you might encounter. If you have any questions or...
  • Page 49 Release pipette plunger from the sample well. or pressure on the transfer tube only after removing pipette tip/transfer tube from sample application well. If the same message repeats, contact Technical Support. CoaguSense, Inc. For In Vitro Diagnostic Use Page 49...
  • Page 50 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Meter Display Possible Cause Solution CLOT TIME The sample clotting Repeat the entire TOO LONG time was very long and procedure (including out of testing range. fingerstick) with a new strip.
  • Page 51 If the second test solution or the storage is out of range, contact of the Coag-Sense Technical Support. Control Strips. ROOM TEMP The temperature of the Move the meter to a...
  • Page 52 Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual Meter Display Possible Cause Solution BAR CODE The strip was inserted Take the strip out and READ incorrectly or there reinsert holding the FAILURE may be a problem with back of the instrument...
  • Page 53 However, the batteries should be replaced as soon as possible. BATTERY TOO The meter batteries Replace batteries to must be replaced. continue with testing. CoaguSense, Inc. For In Vitro Diagnostic Use Page 53...

  • Page 54: Performance Characteristics

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 18. Performance Characteristics Expected Values: Results are reported in INR units equivalent to the plasma reference method. For PT testing, variations in the source of thromboplastin may cause some differences in results between methods.

  • Page 55: Meter Specifications

    (658 g) Equipment Classification Class II with external power supply. Internally powered when operated with batteries. IPXO rating. WARNING: Use only the Coag-Sense AC adapter or damage to the meter may result. CoaguSense, Inc. For In Vitro Diagnostic Use Page 55...

  • Page 56: Warranty

    Limited Warranty CoaguSense warrants that the Coag-Sense meter is free from all defects in material and workmanship for a period of one (1) year from date of purchase. When the meter is used for the intended purpose and in the appropriate manner, the remedy is repair or replacement at CoaguSense’s option.
  • Page 57 OPERATION OF THE METER OR ITS PARTS. NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IS IMPLIED FROM THE SALE OF THE COAG-SENSE PT/INR SYSTEM. NO WARRANTY, EXPRESS OR IMPLIED (IF ANY) SHALL EXTEND FOR A LONGER DURATION THAN THE DURATION OF THE EXPRESS WARRANTY STATED ABOVE.

  • Page 58: Index

    Coag-Sense™ Prothrombin Time (PT)/INR Monitoring System Professional User’s Manual 21. Index AC Adapter, 19 Fingerstick Sample, 31 AC Power, 43, 44 Flashing Green Light, 24, 28, Air Bubbles, 28 Alcohol Wipe, 31 Hazards And Symbols, 17 Bar Code Read Failure, 52...
  • Page 59 Unexpected Results, 30, 32 Room Temp Incorrect, 51 Warnings and Precautions, 12 Sample Collection, 36 Warranty, 56 Sample Transfer Tubes, 38 Wheel Problem, 51 Sharps Container, 31 Squeezing the Fingerstick Site, System Description, 8 CoaguSense, Inc. For In Vitro Diagnostic Use Page 59...

  • Page 62: Technical Support

    Technical Support CoaguSense, Inc. 48377 Fremont Rd., STE. 113 Fremont, CA 94538 Toll Free: 1-866-903-0890 E-Mail: techsupport@coagusense.com CoaguSense, Inc. 48377 Fremont, ste. 113 EMERGO EUROPE Fremont, CA 94538 USA Molenstraat 15 Tel: (510) 270-5442 2513 BH, The Hague Fax: (510-226-6540 The Netherlands Phone: +31.70.345.8570...

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