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CoaguChek® INRange system

More control. More time in therapeutic range.
IVD For in vitro diagnostic use.
CoaguChek® INRange system

CoaguChek® INRange system
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Connectivity

 

Built-in wireless, Bluetooth® technology allows you to be connected to your patients, who can now transmit their PT/INR results from their meter to you. This will help you to keep patients on track and in range–anytime, anywhere.

CoaguChek technology and quality have been recognized to facilitate VKA patient self-testing in a safe, accurate and reliable manner.1

 

More time in range

 

Patients who spend a high proportion of time (> 70%) in the therapeutic range achieve better clinical outcomes.2,3 Studies show that this can be achieved through self-testing using CoaguChek technology1,4

 

More engaged patients

 

Patients who self-test are more engaged in their own care, test more often and spend more time in therapeutic range.4,5

 

Value of patient self-testing

 

Patient self-testing has been shown to result in more time spent in therapeutic range,6-8 fewer very high or very low INR values,8 fewer thromboembolic events,9-10 improved patient quality of life,11,12 and better treatment satisfaction11,13 as compared to usual care or anti-

CoaguChek INRange

The CoaguChek INRange system features

  • Results trend reporting: The CoaguChek INRange meter will let your patients know if their most recent result is higher or lower than their last result to help understand trends.

  • Bluetooth or USB connectivity: Connect the meter to a mobile app via Bluetooth or USB to quickly and easily send results to the healthcare professional. For more information about compatible software for data transfer with the CoaguChek INRange meter please contact your local Roche Diagnostics customer support.

  • Color display: The color display makes important information such as color-coded results noticeable so that they are easy to read and understand.

  • Target range aware: Once you setup targets in your CoaguChek INRange, it will clearly let the patient know about results out of that range.

  • Commenting: The patient can enter up to 6 comments with each result to help them remember any past actions that may have affected the result.

  • Reminders and on-screen help: Reminders can be setup for important events such as when to test, take medication or next doctor's appointment. On-screen help provides text guidance through-out the test procedure.
How to use CoaguChek INRange

System components

  • CoaguChek INRange meter
  • CoaguChek XS Softclix lancing device -for single patient use only
  • CoaguChek Softclix lancets (bag of 10)
  • Carrying case
  • User's manual, Quick reference guide
  • USB cable, 4 x AAA batteries

 

Additional required components

 

  • CoaguChek XS PT Test PST strips (in a vial)
CoaguChek INRange

*Do not use the meter at an altitude higher than 14,000 feet (4,300 meters).

Abbreviations

INR: International Normalized Ratio

PT: Prothrombin time

References

  1. Sharma, P., Scotland, G., Cruickshank, M., Tassie, E., Fraser, C., et al. (2015). Is self-monitoring an effective option for people receiving long-term vitamin K antagonist therapy? A systematic review and economic evaluation. BMJ Open 5:e007758
  2. Gallagher,A.M., Setakis, E., Plumb, J.M., Clemens, A., van Staa, T.P. (2011). Risks of stroke and mortality associated with suboptimal anticoagulation in atrial fibrillation patients. Thromb Haemost 106, 968–977
  3. Wan, Y., Heneghan, C., Perera, R., Roberts, N., Hollowell, J., et al. (2008). Anticoagulation control and prediction of adverse events in patients with atrial fibrillation: a systematic review. Circ Cardiovasc Qual Outcomes 1, 84–91
  4. Ward A, Tompson A, Fitzmaurice D, Sutton S, PereraR., et al. (2015). Cohort study of Anticoagulation Self-Monitoring (CASM): a prospective study of its effectiveness in the community. Br J Gen Pract. 65(636):e428-437
  5. Heneghan C., Ward A., Perera R., et al. (2012). Self-monitoring of oral anticoagulation:systematic review and meta-analysis of individual patient data. Lancet 379:322-334
  6. Bereznicki, L.R.E., Jackson, S.L., Peterson, G.M. (2013). Supervised patient self-testing of warfarin therapy using an online system. J Med Internet Res 15, e138
  7. Christensen, H., Lauterlein, J.-J., Sørensen, P.D., Petersen, E.R.B., Madsen, et al. (2011). Home management of oral anticoagulation via telemedicine versus conventional hospital-based treatment. Telemed J E-Health Off J Am Telemed Assoc 17, 169–176
  8. Bussey, H.I., Bussey M., Bussey-Smith K.L., Frei, C.R. (2013). Evaluation of warfarin management with international normalized ratio self-testing and online remote monitoring and management plus low-dose vitamin k with genomic considerations: a pilot study. Pharmacotherapy 33, 1136–1146
  9. Heneghan, C., Ward, A., Perera, R., Bankhead, C., Fuller, A., et al. (2012). Self-monitoring of oral anticoagulation: systematic review and meta-analysis of individual patient data. Lancet 379, 322–334
  10. Heneghan, C., Alonso-Coello, P., Garcia-Alamino, J.M., Perera, R., Meats, E., Glasziou, P. (2006). Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 367, 404–411
  11. Matchar, D.B., Jacobson, A., Dolor, R., Edson, R., Uyeda, L., et al. (2010). Effect of home testing of international normalized ratio on clinical events. N Engl J Med 363, 1608–1620
  12. Salvador, C.H., Ruiz-Sanchez, A., González de Mingo, M.A., Carmona Rodríguez, M., Carrasco, et al. (2008). Evaluation of a telemedicine based service for the follow-up and monitoring of patients treated with oral anticoagulant therapy. EEE Trans Inf Technol Biomed 12, 696–706
  13. Gardiner, C., Williams, K., Mackie, I.J., Machin, S.J., Cohen, H. (2005). Patient self-testing is a reliable and acceptable alternative to laboratory INR monitoring. Br J Haematol 128, 242–247

Overview

Ordering Information

Technical specifications

Technical specifications

Detection system
 

Amperometric (electrochemical) determination of the PT time after activation of the coagulation with human recombinant thromboplastin

 

User interface
 

Intuitive user interface with color display, on/off, enter, back and up/down button

 

Sample application
 

Outside the meter top-and 2 sides: left or right,-dosing options

Temperature
 

+ 15° C to + 32° C (59° F to 90° F)

 

Humidity
 

10 -85%

 

Maximum altitude
 

4300 m (14,000 ft)

 

Placement
 

-First option: Operate the monitor on a level surface, free of vibrations

-Second option: Hold the monitor in your hand, so that it is roughly horizontal

 

Measuring range INR
 

0.8 -8.0

 

Interface
 

USB (Type B) and Bluetooth

 

Power
 

Battery -Four 1.5v AAA alkali-manganese batteries

# of tests per set of batteries

Up to 60 tests or 1 year

 

Size
 

145 x 75 x 30 mm

 

Weight
 

135 g (without batteries)

 

Memory
 

400 Test Results

 

Auto power off
 

Auto off after 2 minutes of inactivity

Sample type
 

Fresh capillary whole blood

 

Sample size
 

≥ 8 μl

 

Interferences
 

Refer to the test-strip package insert

ISI
 

Approx. 1.0

 

Sensitivity to heparin
 

Not at therapeutic levels, up to 0.8 I.U/ml for UFH and to 2 anti-Xa U/ml for LMWH

 

Quality control
 

On each strip, through the same channel as the blood passes

 

Stability
 

21 months from production (+ 2° C to + 30° C)

 

Color

Display of target range

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