Technology

Gold Standard Accuracy you Require from Assure® PT Care

About PT/INR Testing

A PT test measures the time it takes for blood to form a clot. Most labs will report PT test results using INR which is a calculated measurement that adjusts for laboratory test variances. A PT test is regularly scheduled to monitor prothrombin levels for patients taking warfarin, a blood thinner. Warfarin aids in the prevention of blood clots and conditions that may result like deep vein thrombosis or pulmonary embolism.

The Assure® PT Care PT/INR Monitoring System

The Assure PT Care System offers superior accuracy and precision in a portable format. Measurement of the patient sample uses patented, direct clot technology and measures actual clot time. No algorithms or look-up tables are required. Only a 10-12 µl sample is needed. The sample is applied to the test strip using a transfer tube to place the required amount in the appropriate place. Results are available in less than one minute and can be communicated to providers via USB, Wi-Fi, or Bluetooth. Explore a variety of resources including videos, user manuals, and FAQs.

Experience The Benefits of Superior Accuracy, Precision and Safety With Assure PT Care

The Assure PT Care meter directly measures clot formation, so the time required to perform a test is the actual prothrombin time in seconds. By not using look-up tables or curve fitting algorithms, the Assure PT Care meter offers superior accuracy and precise results in less than a minute.

<1

minute

2.5%

CVs

10-12 μl

sample

Coag-Sense handheld meter

NFC tag in the carton quickly communicates test strip lot information to the meter via NFC scanner on front of meter.

Optional wired or wireless bar code scanner allows patient ID capture for data management.

Multiple connectivity options (wired and wireless) send results data to electronic medical records.

Patient results history is quickly plotted to provide a complete picture of time in therapeutic range.

User-friendly, color touchscreen displays intuitive instructions.

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Proven Methodology

  • Micro-mechanical detection measures actual clotting time for a real PT measurement
  • Offers gold standard accuracy and precision (<2.5% CV)
  • Full reporting range up to 8.0 INR
  • Not susceptible to changes in hemoglobin and hematocrit levels
  • User-friendly color touchscreen with easy instructions
  • Small sample size required, only 10 µL drop of blood
  • Test strips are individually packaged
  • Test strip lot information communicated wirelessly to the meter via NFC chip
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A More Direct Approach to INR

  • The only POC system that directly detects clotting endpoint (emulates the WHO Tilt-Tube method)
  • Offers gold standard accuracy and precision (CV 2.5%)
  • Determines actual PT time without lookup tables or curve-fitting algorithms
  • Displays PT results in less than 1 minute
  • INR range from 0.8 to 8.0
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Simple and Accurate Sample Collection

  • Small sample size – just one 10μl drop of blood
  • Sample transfer tubes included
  • Allows stable, accurate transfer of sample to test strip
  • Reduces errors and strip wastage with correct volume delivery
  • Supports proper bloodborne-pathogen control compliance

Meter Specifications

Operating Temperature65°F to 90°F (18°C to 32°C)
Battery(3.7V, 2350mAh)
Altitude10,000 ft (3,048 m) above sea level
Storage Humidity20% to 80% (without condensation)
Storage Temperature32°F to 122°F (0°C to 50°C)
Lithium BatteryRechargeable Lithium Polymer
MemoryCapable of storing up to:
• 2000 patient test results with date and time
• 500 control test results with date and time
• 1000 Operator accounts
Operating Humidity10% to 90% (without condensation)
Battery CapacityFully charged battery (6 hours of charging) can run ~100 tests
Power Input120V AC Adapter (Use with Assure® PT Care Adapter Only)
AC Input100-240V~, 50-60Hz, 0.5A (Mains supply voltage fluctuation: ±10%
Power Output5.0V, 2.0A
Pollution Degree2
Overvoltage CategoryII
Use CircumstanceIndoor only
Blood Sample Size10-12 μL
Communication PortMicro and Standard USB
Size in mm (Height x Width x Depth)152 x 100 x 29.5
Weight in g315g
Equipment ClassificationClass II with external power supply. Internally powered when operated with battery. IPX0 rating.

Conducting a PT/INR test with the Assure PT Care Meter

Step 1 Hand inserting test strip

Step 1

Insert a test strip

Step 2 Transfer tube getting blood sample

Step 2

Lance finger and collect a bead of blood with sample transfer tube.

Step 3 Applying sample to meter

Step 3

Dispense sample into well located near flashing green light on test strip.

Step 4 Assure PT Care meter front with test results screen

Step 4

Results are ready in less than a minute. (testing time is the patient’s actual clotting time)

Ordering Information and Accessories

350222Assure PT Care PT/INR System (meter only)
350218Assure PT Care Test Strip Kit (50)
Contains: 50 patient test strips, 2 each High and Low control test strips, control activation solution, NFC tag card, sample transfer tubes, package insert
03P52-57Vacuum Sealed Sample Transfer Tubes
351102Assure PT Care Promo 2-pack (1 meter, 2 test strip kits, 1 #980121 100ct safety lancets)
351104Assure PT Care Promo 4-Pack (1 meter, 4 test strip kits, 2 #980121 100ct safety lancets)
Accessories
500016Carrying Case
500019Stylus Pen
200289AC Power Adapter – International
03P76-01Portable Printer (optional)
PD-99906Portable Printer Paper, 5 rolls (optional)
03P78-01Barcode Scanner (optional)

Call your local distributor rep to order a meter or strips. Call ARKRAY USA to order accessories.

Accessories

Assure PT Care Test Strip Kit (50)

Contains: 50 patient test strips, 2 each High and Low control test strips, control activation solution, NFC tag card, sample transfer tubes, package insert

Assure PT Care TS carton

Vacuum Sealed Sample Transfer Tubes

Vacuum Sealed Sample Transfer Tubes

Carrying Case

Hands holding Assure PT Care meter

Portable Printer (optional)

Portable Printer

Scanner (optional)

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