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Patents Pending. Coag-Sense® is a registered trademark of CoaguSense, Inc.

These materials are made available here for the personal use of current and prospective customers and users of Coag-Sense® diagnostic products and monitoring systems. They are provided for informational and demonstration purposes only and are not to be copied, redistributed or published in any manner.

Coag-Sense® products should only be used for their intended purpose with a doctor’s prescription, as directed and in accordance with the applicable User’s Manual. 

Do not use Coag-Sense® products without talking with your doctor or health care professional.

Additional precautionary usage notices and warnings are contained in the User’s Manuals and should be read carefully before use.

It takes 6 hours to fully charge the battery. However, you can use the meter after a charge of 30 minutes. There is a battery icon on the upper right side of the display. This will indicate when the meter is charging and how much charge is in the battery.

When you are finished with your test, please remember to turn the meter off completely by pressing and holding the power button until it turns off. If the meter is not turned off, but left in the Sleep mode, it will drain the battery.

There is an NFC Tag provided with the patient test strips. The NFC Tag scanner, which can be found on the top of the meter, reads the data stored in the NFC Tag and auto populates the lot and barcode information into the meter. This is accomplished by physically placing the NFC Tag directly onto the corresponding symbol on the meter (not on the display).

In the absence of an NFC Tag, the user may manually enter the lot and barcode numbers using the keypad on the touch screen. A stylus with a rubber capacitive tip may be used to facilitate typing. The lot and barcode numbers are located on each test strip pouch.

In the Device Settings section of the meter you will see Date Format, Time Format and Date/Time. The Format options are to set the format in which you would like to see the date and time; they do not set the date and time. In order to set the correct date and time use the Date/Time option under Device Settings. When you tap on Date/Time, you will see rectangular boxes where you can manually set the correct date and time. Remember to tap on Confirm after completing this task. (The meter will automatically adjust for Daylight Savings Time.) Please review our training videos for more information.

Remove the strip and begin again. When the meter displays “Please Insert a Strip”, insert the strip straight, fairly quickly and all the way to the back. If you have an error again, try another strip. It the problem persists, call Technical Support at 866-903-0890.

To eliminate the need to enter a Patient ID, Tap on Settings from the homepage. Choose Admin Settings and then deselect Patient ID Required.

While bridging, a lab draw is recommended. Please refer to the Limitations section in the Package Insert of the patient test strip kit.

It is important to use only a 21-gauge lancet with a depth of 1.8 to 2.2mm. This is to ensure the correct volume and correct type of sample. The goal is to have free flowing blood with no milking of the finger. Excessive “milking” of the finger releases interstitial fluid (tissue factors) that can cause unreliable results.

Differences in reagents, instruments, and pre-analytical variables can affect prothrombin time results. These factors should be considered  when comparing different prothrombin time test methods. 

If you are a self-tester please contact your service provider directly, using the phone number provided on your paperwork. For professional users please contact your Distributor.

Please contact your service provider directly, using the phone number provided on your paperwork.

Please contact your service provider directly, using the phone number provided on your paperwork.

If you are a home-tester please contact your service provider directly, using the phone number provided on your paperwork. If you are a professional user please contact CoaguSense.

The meter is approved for oral Coumadin monitoring only. It should not be used for patients being treated with any direct thrombin inhibitors including Hirudin, Lepirudin, Bivalirudin, Argatroban, and ​Dabigatran (Pradaxa) or Factor Xa inhibitors including Rivaroxaban (Eliquis), Apixaban (Xarelto), Endoxaban, and Fondaparinux. The results obtained cannot be used for the determination or the assessment of a therapy ​with factor II or factor X antagonists.

Follow the guidance in the troubleshooting section of the User Manual for the specific error message. If you still have questions, please contact Technical Support at 866-903-0890.

CoaguSense recommends repeating the test if a result seems unusually low or high. Be sure to use a different finger and all new supplies. Follow the recommended timing and technique. If you still have questions, please contact Technical Support at 866-903-0890.

The Coag-Sense PT/INR does not require any maintenance or calibration – ever. Whenever a strip is inserted, the meter does a self-check before allowing testing to commence.

Washing with soap and warm water is best practice. Antiseptic wipes should not be used. If alcohol swab is used make sure finger is dried before performing fingerstick.

From the Homepage, tap on the brick-colored box in the lower right corner. Tap on the second line from the top. Tap on the second line from the top again. Then select English and press the rectangular box in the lower right corner. After a few seconds, the meter will then display in English.

Controls are run on every meter prior to the shipment from the factory. Controls are a regulatory requirement for professional offices (not self-testers). Each patient test strip kit contains 2 High and 2 Low control strips. Additional control strips can be ordered through your distributor using Catalog# 03P69-10.

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Please contact Technical Support at 866-903-0890 for login assistance.

Refer to the package insert located in the Test Strip Kit Box for the limitations of procedures.

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. The warranty does not apply to a meter damaged by misuse, alteration or tampering to either the hardware or software. Contact Technical Support at 1-866-903-0890 for instructions.

When connected to the Internet, the Coag-Sense meter can check for available software updates which can be downloaded. Updates can be downloaded in the Software version option located in Device information. It is recommended to check periodically for available software updates.

Please refer to the user’s manual and available training videos located on the website for user instructions. For additional assistance, contact Technical Support at 1-866-903-0890 .

Yes. CLIA-Waiver Number: K183255

The meter housing can be cleaned and disinfected by wiping all exposed surfaces with Healthcare Bleach Germicidal Wipes containing Sodium Hypochlorite (EPA No. 67619-12) for a contact time of 1 minute to pre-clean blood and other body fluids. Caution should be taken to not get fluids inside the meter through the test strip port, data transmission port or battery compartment. Dispose of the used towelette. The meter should be allowed to air dry before use.

INR 0.8 to 8.0

The sample clotting time was very long and out of testing range or there was insufficient sample transferred to the test strip. Possible causes include; improper lancing (21g lancet required), an air bubble in the sample or not allowing sample to completely fill the transfer tube. Confirm that the patient has not recently taken heparin or other contraindicating drugs listed on the test strip package insert. Repeat the entire procedure with a fresh fingerstick and a new strip. If the same message displays, use an alternative testing method and contact Technical Support.