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CoaguChek XS® system - The smart way to test INR at home

Since 1993, CoaguChek systems have set the standard for precision in point-of-care prothrombin time (PT/INR) testing for patients on oral anticoagulant (VKA) therapy – giving clinicians confidence in making critical treatment decisions.

Roche, the pioneer in Coagulation Monitoring systems, introduced in 2006 the CoaguChek XS system, its latest generation of Coagulation Monitoring system. It is dedicated to patients on VKA therapy testing at home or on the go.

It is CE marked and FDA approved (also CLIA-waived in the US).
It is now registered in most countries around the world.
Please check with your local Roche representative to make sure about its availability in your country.

The CoaguChek XS system replaces the first models launched by Roche, the Roche CoaguChek system (1993), and its successor (2000), the CoaguChek S system, still in use but not available anymore.

It produces results equivalent to those obtained with reference laboratory methods and also compares very closely to the professional device, the CoaguChek XS Plus system, as it uses the same technology and the same strips.

It offers several practical and safety features:

  • Practical features: easy portability, side and top blood dosing options, simple user interface
  • Safety features: onboard quality control (QC) for each strip (integrity check), optional QC lockout to meet potential regulatory requirements

 

The Roche CoaguChek XS system provides patients with more independence and enhanced quality of life .It also increases potentially their compliance, hence their protection.

More than two million patients on VKA around the world are currently tested with a CoaguChek system: you can therefore feel confident that you are making the right decision when selecting today a CoaguChek XS system for your selected and trained patients testing at home.

 














CoaguChek® XS system - A comprehensive yet simple system

The CoaguChek XS instrument kit consists of different components. The following components are included:

  • Carry case, which allows the patient to keep all items incl. 1 vial of test strips in their proper place
  • CoaguChek XS meter
  • CoaguChek Softclix lancing device - for single patient use only (Accu-Chek Safe-T Pro Plus - for use in multiple patients settings)
  • 4 x AAA batteries

 

Additional required components are PT strips (in a vial):

  • Box with 2 vials of 24 strips each with a code chip
  • Box with 1 vial of 24 strips with a code chip

Confidence is the key to therapy success

Measuring & sampling
Detection systemAmperometric (electrochemical) determination of the PT time after activation of the coagulation with human recombinant thromboplastin
User interfaceSimple user interface with icon based LCD and On/Off-, Mem- and set-Button
Sample applicationOutside 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 and height10 - 85% - 4300 m
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 rangeINR: 0. 8 - 8.0
Memory100 test results with time and date
InterfaceInfrared
Power

# of tests per set of batteries
Battery - Four 1.5v AAA alkali-manganese batteries

Up to 300 tests or 2 years
Size138 x 78 x 28 mm
Weight127 g (without batteries)

Sample Material
Sample typeFresh capillary whole blood or non-anticoagulated venous whole blood
Sample size8 µl
InterferenceRefer to the test strip package insert.

Test strips
ISIApprox. 1.0
Sensitivity to heparinNot at therapeutic levels, up to 0.8 I.U/ml for UFH and to 2 anti-Xa U/ml for LMWH
Quality controlOn each strip, through the same channel as the blood passes
Stability21 months from production (+ 2° C to + 30° C)

As fast and easy as it looks

Before using the monitor for the first time, carry out the following steps:

  1. Insert the batteries
  2. Insert the code chip (you can also carry out this step immediately before testing)
  3. Set the current date and time
  4. Select the coagulation unit in which the results are to be displayed
 

 

 

Then ...

 

Insert a test strip in the CoaguChek XS system

The code number of the code chip inserted in the monitor flashes in the display. Make sure that this number is identical with the code number printed on the test strip container. If the two numbers are identical, confirm by pressing the M button.

 

Prick the finger of your patient with a lancet device approved for professional use (e.g. the Accu-Chek Softclix Pro or Accu-Chek Safe-T-Pro device)

The blood drop symbol and the application area flash to indicate that the monitor is ready to test. At the same time a 120-second countdown begins. Within this time you must have applied the drop of blood.

And ...

 

...place a drop of blood on the strip

Apply the blood directly from the finger to the semicircular, transparent sample application area of the test strip. Apply the blood drop to the test strip within 15 seconds of pricking the fingertip.
Alternatively, you can touch the blood drop against the side of the sample application area (instead of applying it to the centre from above).

 

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

Result can be displayed in:

  • INR
  • Seconds
  • % Quick