Description
*FOR IN HOME USE RX NEEDED TO PURCHASE
PT2 Self-Test User-Manual
PT2 Self-Test Quick Reference Guide
PT2 Performance Evaluation Study
Unit: 1 Each
Contents: (1) PT2 Analyzer, (1) Self-Test Quick Reference Guide, (1) Self-TestUser Manual, (1) Micro USB Adapter, (1) Power Supply, (8) Auto Single Use Lancets, (54) Sample Transfer Tubes with Plungers PRELOADED, (1) Carrying Case
Determinations: Prothrombin Time (PT)/INR
Equipment Storage Requirements: 59° – 86° F
Sample Volume: 10 uL
Processing Time: <1 minutes
Power Source: Built-in Lithium polymer rechargeable battery
The Coag-Sense® PT/INR Monitoring System represents a breakthrough in point-of-care prothrombin time monitoring technology by miniaturizing and simplifying a direct mechanical means of detecting clot formation. Coag-Sense® is the only true prothrombin timer on the market. Now you can get direct clot detection PT/INR technology in a sleek little package with all the bells and whistles including Wi-Fi, Bluetooth®, Near Field Connectivity (NFC) and a color touch screen to control it all.
For self-test users, the CoaguSense® 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. It uses fresh capillary whole blood.
The device is intended for use by properly selected and suitably trained patients or their caregivers on the order of the treating physician to monitor patients who are on anticoagulation therapy. Patients should be stabilized on warfarin-type (coumarin) anticoagulation therapy prior to self- testing. The device is not intended to be used for screening.
PT2 Features:
- Size – PT2 fits in a pocket
- Color touch screen display – easy to follow instructions in plain language
- Connectivity – Wi-Fi, Bluetooth, Ethernet, USB
- POCT-1A interface – Telcor and RALS drivers available starting Q2
- Near Field Communication (NFC) – replaces bar code reader to communicate test strip lot information
- Operator ID and patient ID – enter manually or via barcode scanner
- Rechargeable Lithium Polymer battery – micro USB charging
- Expanded Memory- 2,000 patient test results and 500 QC results
- Test Strips up to 24 month shelf life
- Additional languages capabilities – Spanish will be added first
- Small Sample Size – 10uL
- Level 1 & Level 2 plasma controls (no other system offers true controls)
- Reagents – Bar coded, room temp storage, up to 24 month expiration
- POL (CLIA waived) AND PST cleared (better standardization)
- ISI ~1.0
- Best Precision available in a POC PT/INR system (CV= 2.5%)
The Coag-Sense® system is used to test prothrombin time (PT) in patients taking Warfarin for oral anticoagulant therapy. Results are reported as International Normalized Ratio, or INR units, and PT seconds.
Because the system directly detects clot formation, it reports true PT-seconds. The Coag-Sense system consists of a meter and single-use PT strips and control strips, along with certain accessories required for testing.
