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    CoaguChek INRange: The new standard in VKA monitoring

     

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

CoaguChek® INRange system

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

 


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 allow 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

More engaged patients

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

Value of patient self-testing

Patient self-testing has been shown to result in more time spent in the 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 anti-coagulation clinic.

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CoaguChek® INRange system

 

 

 

 

When you’re connected, your patients are on track

 

You’ll be truly connected to your patients, so you can confidently optimize their therapy

 

 

 

 

 

Key features

 

The CoaguChek INRange offers more information than just a result in order to encourage a better connection between the patient and healthcare professional. With trending reports, comments and color-coded graphs, you can quickly see where your patients’ PT/INR is heading.

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.

Target range aware

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

Bluetooth or USB connectivity

Connect the meter using 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.

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.

Color display

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

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.

 

System components

 

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)

 

How to use the CoaguChek INRange

 

Step 1

Step 1

Put a test strip in the CoaguChek INRange

Step 1

Step 2

Prick your finger with the Roche Softclix XS lancing device

Step 1

Step 3

Place a drop of blood on the strip

Step 1

Step 4

After about one minute, read the result on the CoaguChek INRange display

CoaguChek INRange system handling video

 

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 color 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

Color

Display of target range

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, Perera R., 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