Resources
Assure® PT Care Training Videos & FAQs
Training Videos
Assure® PT Care PT/INR Monitoring System
System Overview
Performing a Control Test
Performing a PT Test
Meter Setup
Care and Maintenance
Documents
FAQs
Meter Setup and Functionality
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 off the meter completely by pressing and holding the power button until it turns off. If the meter is not turned off and left in the Sleep mode, it will drain the battery.
Yes. You can test while the meter is on the charger. The meter should be on the charger for at least 30 minutes before attempting a test.
We do not recommend leaving the meter on the charger when it is fully charged.
There is an NFC Tag card provided in the patient test strip carton. Place the NFC Tag card over the NFC Tag scanner found on the top of the meter. This action automatically transfers the data stored in the NFC Tag and auto populates the lot and barcode information into the meter.
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 allow you to choose the preferred format for date and time. 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.
To eliminate the need to enter a Patient ID, Tap on Settings from the homepage. Choose Admin Settings and then deselect/turn off Patient ID Required.
Please contact Technical Support at 800.818.8877 for login assistance.
From the Homepage, tap on Settings > Device Settings > Language > and choose English from the choices listed, press Confirm. After a few seconds, the meter will display in English.
When connected to the Internet, the Assure PT Care meter can check for available software updates which can be downloaded. Choose Settings > Device Information > Software version. In this screen, it will indicate if a new version is available which can be downloaded by clicking on the New version button. It is recommended to check periodically for available software updates. It is recommended to have a fully charged battery or be connected to power when downloading a new version of software.
Quality Control
The Assure PT Care PT/INR does not require any maintenance or calibration. Whenever a strip is inserted, the meter does a self-check before allowing testing to commence.
Refer to the package insert located in the Test Strip Kit Box for the limitations of procedures.
Controls are run on every meter prior to shipment from the factory. Controls are a regulatory requirement for professional offices. Each patient test strip kit contains 2 High and 2 Low control strips. Additional control strips can be ordered through Coag-Sense at 1-866-903-0890.
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.
Patient Testing
It is important to use only a 21-gauge lancet with a depth of 1.8 to 2.2mm. This ensures the correct volume and 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.
Antiseptic wipes should not be used. Wipe finger with an alcohol swab and dry with gauze to ensure finger is dry before performing a fingerstick.
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.
INR 0.8 to 8.0
Troubleshooting
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 800.818.8877.
Remove the strip and begin again. When the meter displays “Please Insert a Strip”, quickly insert the strip straight and all the way to the back. If you have an error again, try another strip. If the problem persists, call Technical Support at 800.818.8877.
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.
ARKRAY 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 800.818.8877.
Please contact your ARKRAY USA rep for in-service training for your facility. You can also refer to the User’s Manual and the training video located on the website, Assureptcare.com, for user instructions. For additional assistance, contact Technical Support at 800.818.8877.
Yes. CLIA-Waiver Number: K183255.
Ordering Details
- 350222 ASSURE® PT CARE PT/INR SYSTEM (meter only)
- 350218 ASSURE® PT CARE PT/INR TEST STRIP KIT
- 980121 ASSURE® Lancet Safety, SINGLE USE, 21G, 1.8mm depth – BOX OF 100
- 03P52-57 COAG-SENSE® Pre-loaded Sample Transfer Tubes
- 03P69-10 Coag-Sense Control Strip Kit (5 high, 5 low, control activation solution)
ARKRAY warrants that the Assure PT Care meter is free from all defects in material and workmanship for a period of one (1) year from the date of purchase. When the meter is used for the intended purpose and in the appropriate manner, the remedy is repair or replacement at ARKRAY’s option. The warranty does not apply to a meter damaged by misuse, alteration or tampering with either the hardware or software. Contact Technical Support at 800.818.8877 for instructions.
Medication Management
The meter is approved for oral Coumadin monitoring only. It should not be used for patients being treated with any direct thrombin inhibitors, known as Direct Oral Anticogulants (DOACs) 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.
While bridging, a lab draw is recommended. Please refer to the Limitations section in the package insert.
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.
The video, content, resources and other materials on this page contain proprietary and copyrighted information of ARKRAY, Inc. Copyright © 2023. All rights reserved.
Patents pending. Coag-Sense® is a registered trademark of CoaguSense, Inc. Assure® is a registered trademark of ARKRAY, Inc.
These materials are made available here for the professional use of current and prospective customers and users of Assure PT Care PT/INR Monitoring System. They are provided for informational and demonstration purposes only and are not to be copied, redistributed, or published in any manner.
The Assure PT Care PT/INR Monitoring System should only be used for its intended purpose with a doctor’s prescription, as directed and in accordance with the applicable User’s Manual.
Additional precautionary usage notices and warnings are contained in the User’s Manual and should be read carefully before use.