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Description

The Coag-Sense PT2 PT/INR Professional Monitoring System includes a PT2 Pro Meter, Pro User's Manual, Pro Quick Reference Guide, Bag of eight Auto Single Use 21G Lancets, AC wall adapter, (54x) Sample Transfer Tubes (#03P52-57), and a carrying case.

Note: Professional Use systems can only be shipped to licensed medical professionals / medical facilities and are not sold to individuals.

Warranty: 1 Year.

The PT2 PT/INR Professional Monitoring System is used to test prothrombin time in patients taking Warfarin for oral anticoagulant therapy. This system reports true PT-seconds.

Features

Coag-Sense PT2 PT/INR Professional Monitoring System Features

  • Proven Methodology:
    • Micro-mechanical detection process offers superb accuracy and precision.
    • Not susceptible to changes in Hemoglobin and Hematocrit levels.
    • Ability to run whole blood, real plasma controls, and plasma calibrants.
    • Testing time is patient's actual clotting time.
    • Only CLIA-Waived system that produces a true prothrombin time.
    • Linear response even in the high INR range.
  • Direct INR Approach:
    • The only POC system that directly detects clotting endpoint.
    • Determines actual PT time without lookup tables or curve-fitting algorithms.
    • Displays PT results in less than one minute.
    • INR range from 0.8 to 8.0.
  • Simple and Accurate Sample Collection:
    • Small sample size - only one 10 µl drop of blood required.
    • Allows stable accurate transfer of sample to test strip.
    • Reduces errors and strip wastage with correct volume delivery.
    • Supports proper bloodborne-pathogen control compliance.
  • Self-Testing:
    • More frequent results benefit patients.
    • Testing at home is a safe and convenient option.
    • Simplicity of design gives better confidence in results.
    • Offers full Point-of-Care reportable range of up to 8.0 INR.
    • Conveniently portable, connected design.
  • Continuum of Care:
    • Consistency of monitoring from hospital, to clinics, to home; with the same meter, same test strips, same reportable range.
    • Safety profile puts both home testers and their clinicians at ease.
    • Included sample transfer tubes ensures proper blood volume and technique.
    • Communicates patient's home testing results to provider.
    • Improve testing adherence with test frequency monitoring and easy supply fulfillment requesting.
    • Medicare covers weekly home PT/INR monitoring for patients with a variety of conditions.
    • Independent Diagnostic Testing Facility (IDTF) supervision ensures compliance.
    • Superb IDTF home testing partners.

Specifications

Coag-Sense PT2 PT/INR Professional Monitoring System Specifications

  • Measuring Range: INR 0.8 to 8.0.
  • Operating Temperature: 65 to 90 °F (18 to 32 °C).
  • Operating Humidity: 10 to 85% (without condensation).
  • Storage Temperature: 32 to 122 °F (0 to 50 °C).
  • Storage Humidity: 20 to 80%.
  • Memory: Capable of storing up to:
    • 2000 patient test results with date and time.
    • 500 control test results with date and time.
    • 1000 Operator accounts.
  • Lithium Battery: Rechargeable Lithium Polymer Battery (3.7 V, 2350 mAh).
  • Battery Capacity: Fully charged (6 hours of charging) can run about 200 tests.
  • Power Input: 120 V AC Adapter (Use with Coag-Sense Adapter Only).
  • Power Output: 5.0 V, 2.0 A.
  • Display: TFT color LCD touch screen.
  • Connectivity Interface: POCT1A/HL7 to LIS/HIS/Middelware.
  • Sampling Method: 21 g lancet; sample transfer tube.
  • Blood Sample Size: 10 to 12 µL.
  • Communication Port: Micro and Standard USB.
  • Size: 152 mm (H) x 100 mm (W) x 29.5 mm (D).
  • Weight: 11.3 oz (0.32 kg).
  • Equipment Classification: Class II with external power supply. Internally powered when operated with battery IPX0 rating.

Configurations

Coag-Sense PT2 PT/INR Professional Monitoring System Configurations

  • #03P70-01: Home Use/Self-Test System.
  • #03P70-02: Professional Use System.
  • #06F74-01: Professional Use System - Includes 1 Box of Coag-Sense Test Strip Kits (#03P57-50 / 50 Tests per Box).
  • #06F74-03: Professional Use System - Includes 3 Boxes of Coag-Sense Test Strip Kits (#03P57-50 / 50 Tests per Box).
  • #06F74-05: Professional Use System - Includes 5 Boxes of Coag-Sense Test Strip Kits (#03P57-50 / 50 Tests per Box).

Accessories

Coag-Sense PT2 PT/INR Professional Monitoring System Accessories

The following accessories and supplies are compatible and commonly purchased with the PT2 PT/INR Professional Monitoring System:

  • #03P57-50: Coagulation Test Kit with Professional Prothrombin Time Test - PT/INR (50 Tests/Case).
  • #03P58-04: Safety Lancet Needle (100/Box).
  • #03P74-01: PT2 Power Supply.
  • #03P75-01: PT2 Carrying Case.
  • #03P76-01: PT2 Portable Printer.
  • #PD-99906: PT2 Portable Printer Paper (5 Rolls).

Frequently asked questions

Is superb micro-mechanical detection used?

Yes, the Coag-Sense PT2 PT/INR Monitoring System utilizes a micro-mechanical detection process known for its superb accuracy and precision in measuring Prothrombin Time (PT) and INR.

This proven methodology offers several key advantages:

  • True PT Measurement: It is the only CLIA-Waived system that reports a true prothrombin time (PT-seconds). It directly determines the clotting endpoint without relying on lookup tables or curve-fitting algorithms, ensuring highly reliable results.
  • Interference Resistance: The mechanical detection is not susceptible to common interferences caused by variations in Hemoglobin or Hematocrit levels, providing consistent results across patient samples.
  • Rapid and Wide Range: Results are displayed in less than one minute. The system supports a full Point-of-Care reportable INR range from 0.8 up to 8.0.
  • Minimal Sample Volume: Testing only requires a very small blood sample size of 10 µL.
Does the Coag-Sense PT2 report true PT-seconds?

Yes, the Coag-Sense PT2 PT/INR Monitoring System is specifically designed to report true Prothrombin Time (PT-seconds). This is a critical advantage for professional testing.

This high accuracy is achieved using a proven micro-mechanical detection process, which is the only CLIA-Waived methodology to produce a true PT result. Instead of relying on lookup tables or algorithms, the system uses a Direct INR Approach to precisely detect the actual clotting endpoint.

Key benefits of this methodology include:

  • Precision: Results are highly accurate and are not susceptible to variations in Hemoglobin or Hematocrit levels.
  • Speed: Results are delivered in less than one minute.
  • Efficiency: Requires only a small sample size of 10 to 12 µL of whole blood.
Is only a 10 µL sample required?

Yes, the Coag-Sense PT2 system requires a remarkably small sample size, which is a key feature for patient comfort and testing efficiency.

  • Minimal Volume: Only 10 to 12 µL of whole blood is required to perform accurate Prothrombin Time (PT) and INR measurements. This is equivalent to approximately one small drop of blood.
  • Precision Sampling: The system uses specialized Sample Transfer Tubes (54 included in the Professional User kit) to ensure the precise 10 µL volume is collected and transferred to the test strip. This high-precision method helps minimize user error and prevents test strip waste.
How many tests does the rechargeable battery support?

The Coag-Sense PT2 system uses a robust rechargeable Lithium Polymer battery (3.7 V, 2350 mAh) to ensure portability and continuous professional use.

Key performance metrics for the battery include:

  • Capacity: It supports approximately 200 tests per full charge.
  • Recharge Time: A full charge requires about 6 hours.

For proper functioning and safety, the meter must only be charged using the dedicated 120 V AC Coag-Sense adapter provided.

Does the system offer professional LIS/HIS connectivity?

Yes, the Coag-Sense PT2 system is specifically designed for professional point-of-care use, offering robust connectivity for integrating with healthcare networks.

Key connectivity features include:

  • Connectivity Interface: Supports the industry-standard POCT1A/HL7 protocol for seamless communication with LIS, HIS, and Middleware systems.
  • Communication Ports: Includes both Micro USB and Standard USB ports for data transfer.
  • Internal Memory: Stores up to 2000 patient test results (with date/time), 500 control test results, and 1000 Operator accounts.
What essential accessories are included with the PT2 system?

The Coag-Sense PT2 PT/INR Professional Monitoring System includes everything needed for professional point-of-care testing, ensuring you’re ready to go right out of the box:

  • PT2 Pro Meter: The core monitoring device.
  • Comprehensive Documentation: Includes the Pro User’s Manual and Pro Quick Reference Guide.
  • Power and Portability: An AC wall adapter for charging and a durable carrying case for easy transport and protection.
  • Efficient Sample Collection: Comes with a bag of eight Auto Single Use 21G Lancets and 54 Sample Transfer Tubes for precise 10 µl blood collection, supporting accurate testing and compliance with bloodborne-pathogen control.

While this standard configuration provides the meter and essential collection accessories, professional use systems are also available in variants that bundle the meter with various quantities of 50-count Test Strip Kits to suit your specific facility’s needs.

Does the Coag-Sense PT2 system support home self-testing?

Yes, the Coag-Sense PT2 system is available in configurations specifically designed for Home Use/Self-Test, making it suitable for patients managing Warfarin therapy at home.

This system ensures a continuum of care, offering consistent monitoring from hospital to clinic to home. Key benefits for home use include:

  • Proven Methodology: Utilizes a micro-mechanical detection process for superb accuracy and precision, unaffected by hemoglobin and hematocrit levels.
  • Rapid Results: Displays PT and INR results in less than one minute.
  • Simple Sample Collection: Requires only a small 10 µl drop of blood.

Please note: While there is a home use variant, the Professional Use system is restricted and can only be shipped to licensed medical professionals or facilities, not to individuals.

Does it report accurate INR values?

Yes, the Coag-Sense PT2 provides true prothrombin time results and reports accurate INR values. It is the only CLIA-Waived system that directly detects the clotting endpoint without relying on lookup tables or curve-fitting algorithms, ensuring superb accuracy and precision.

Is the system susceptible to Hemoglobin changes?

No, the Coag-Sense PT2 system is not susceptible to changes in Hemoglobin and Hematocrit levels, ensuring consistent and reliable results regardless of these variations in the patient’s blood.

Is the Coag-Sense PT2 reliable for accurate PT/INR monitoring?

Yes, the Coag-Sense PT2 PT/INR Monitoring System is highly reliable and is designed for professional-grade diagnostic accuracy. It stands out by using a micro-mechanical detection process that directly detects the clotting endpoint to report actual PT-seconds and INR. Unlike other systems that rely on curve-fitting algorithms or lookup tables, this method ensures that your results are not susceptible to variations in Hemoglobin or Hematocrit levels. Key reliability features include:

  • Proven Precision: Provides accurate, true PT-seconds, facilitating consistent monitoring in both clinical and home care settings.
  • Hygienic Architecture: Engineered so that the blood sample does not come into contact with the device’s internal components, which helps minimize maintenance and contamination risks.
  • Clinical Flexibility: Offers a broad reportable INR range of 0.8 to 8.0, making it suitable for a wide variety of patient needs.