CoaguChek^® INRange system

More control. More time in therapeutic range.

More control. More engaged patients. More time in therapeutic range.

CoaguChek® INRange is the connected self-testing meter that enables your patients to test their INR whenever, wherever* - for confident control of their VKA therapy.

Do you have any questions?

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 recognised 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 technology.^1,4

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 satisfaction^11,13 as compared to usual care or anticoagulation clinics.

Key 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.
Colour display: The colour display makes important information such as colour-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 set up for important events such as when to test, take medication or book a doctor's appointment. On-screen help provides text guidance throughout the test procedure.

How to use CoaguChek INRange

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The CoaguChek INRange kit consists of the following 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)

References

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
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
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
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
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
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
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
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
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
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
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
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
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

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

Abbreviations

INR: International Normalised Ratio

PT: Prothrombin time

Technical specifications

Measuring & Sampling

Detection system

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

User interface

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

Sample application

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

Operating conditions

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 material

Sample type

Fresh capillary whole blood

Sample size

≥ 8 μl

Interferences

Refer to the test-strip package insert

Test strips

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)

Display

Colour

Display of target range

CoaguChek® INRange system