• CoaguChek XS® systems

    The smart way to test INR at the Point of Need

CoaguChek® XS Pro

CoaguChek__XS_Pro_system

PT/INR Monitoring tailored to hospital point of care testing

  • Barcode reader for faster ID entry
  • Time critical INR results - faster than sending them to the lab
  • Electronic data capture and transmission aid compliance with accreditation and regulatory standards such as JCI and CLIA '88.

Greater Convenience

Healthcare professionals can measure PT/INR values in approximately 1 minute with a drop of capillary blood (8 µL).

In order to ensure compliance and improve workflows, the system allows patient and operator ID identification with its integrated barcode scanner. Connecting the instrument to the institution’s data management system finally assures safe and efficient patient management

On-the-spot results, no venous sampling

Easy portability; side and top blood dosing options with a capillary sample

Greater Safety

Onboard quality control (QC) for each strip; optional QC lockout to meet potential regulatory requirements; consistent INR results

Greater Workflow Efficiency

Positive patient and/or operator identification, extensive data management and connectivity options. 

To learn more about the CoaguChek XS Pro system for your institution select your country from the map on the right.

CoaguChek-XS-Pro-set

The CoaguChek® XS Pro instrument kit contains:

  • 1 CoaguChek XS Pro instrument
  • 1 Handheld power supply unit
  • 1 printed manual in English
  • 1 CD-ROM with other languages: German, French, Italian, English, Spanish, Portuguese, Danish, Norwegian, Swedish, Finnish and Dutch

Additional required components are CoaguChek XS PT Test strips (in a vial)

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

 Optional accessories

  • Handheld base unit kit: docking station (to reload the battery pack and transfer data to a computer)
  • Handheld battery pack: option instead of standard batteries or power supply (to gain flexibility)

Optional international 1 level CoaguChek XS PT-control kit including:  See comment for XS Plus4 vials with a concentration of ~ 2.0 INR

  • 4 diluent-filled droppers
  • 1 code chip
  • Package insert

To receive more information about the CoaguChek XS Pro, select your local affiliate from the map on the right.

Measuring & Sampling    
Detection system Amperometric (electrochemical) determination of the PT/INR after activation of the coagulation with human recombinant thromboplastin  
User interface Full graphical (TFT)  
Support and safety functions QC lockout, Patient & User ID, protection with administrator ID. Barcode Scanner  
Sample application Outside the meter, with top- and 2 sides (left or right)-dosing options  
Operating Conditions    
Operating Temperature

+15° C to +32 °C (59 °F to 90 °F)

 
Operating humidity and altitude 10 - 85% - 4300 m  
Handling - First option: Operate the monitor on a leveled 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; %Q: 120 - 5; SEC: 9.6 - 96  
Memory 2000 patient and 500 QC results with date and time. 60 code chip records.
Operator list with up to 5000 Operator IDs with corresponding 2nd ID.
Patient list with up to 4000 Patient IDs with corresponding 2nd and 3rd patient IDs.
 
Interfaces Infrared interface  
Power options - Power supply adaptor: input: 100-240 V / 50-60Hz / 400 mA; output: 7.5 V DC/ 1.7 A
- 4 x 1.5 V AA batteries (alkali-manganese)
- Rechargeable battery pack (optional)
 
Number of tests per set of batteries Approx. 80 tests (approx. 60 tests per charging cycle if the rechargeable battery pack is used).  
Dimensions 231 x 97 x 43 mm  
Weight 350 g (without batteries)  
Sample Material    
Sample type Fresh capillary whole blood or non-anticoagulated venous 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)  

If you would like to learn more about using the CoaguChek XS Pro for point of care testing in your hospital, select your local country on the right to visit your local CoaguChek website.

Roche Diagnostics offers full competency training with every CoaguChek XS Plus and Pro purchased. This will go through all aspects of patient testing, QC testing and maintenance of your instrument. To arrange this please contact us on 0508 69 54 33.

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CoaguChek XS Plus and Pro:

Check with your local Roche team for training on the CoaguChek XS Plus and Pro. Typically this training will be handled by them once the devices are on site due to the extensive data management and configuration capabilities these instruments offer.

Below you can watch an introduction to the handling of the CoaguChek Plus and CoaguChek Pro.

CoaguChek XS Plus handing video

CoaguChek XS Pro handling video

CoaguChek XS systems handling videos

 

CoaguChek XS handling video


CoaguChek XS - Training for your patients:

Depending on your location, there are different training options available to you and your patients.

  • Training Centers – In some areas, training centers have been set up to give face to face training to your patients.  Contact your local Roche organization to find out more.
  • CoaguChek Academy – Many countries offer an online eLearning option called Coaguchek Academy.
  • Phone support – Most countries offer excellent phone support for your patients, these patient and supportive staff are trained to walk your patients through setting up their meter and performing their first test.
  • CoaguChek XS handling video - A handling video is available to walk them through setting up and testing with the CoaguChek XS in the Patient side of www.coaguchek.com
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What is the recommended test frequency?

At least twice per month, preferably once per week. This has proven to increase TTR by enabling faster reactions to variations in INR due to exercise and diet. It also increases patient compliance and engagement. (1,2,3)

What is time in therapeutic range (TTR)?

The percentage of time that your patient’s INR values fell within the upper and lower target value set by you.

Do the CoaguChek XS Pro systems need calibration?

Calibration is performed automatically upon inserting the code key from the strip vial.

What steps can I take when the readings are different to the hospital lab?

Due to diverse measurement standards used by labs, small variations should be expected.  If the variation is of therapeutic significance, please contact your support team at Roche Diagnostics NZ on 0508 69 5433.

Are there interferences when testing with CoaguChek systems?

Polyglobulism: Hematocrit outside the standard range (25 - 55%)
Lupus anticoagulant: INR abnormally high

The presence of anti-phospholipid antibodies (APAs) such as Lupus antibodies (LA) can potentially lead to prolonged clotting times, i.e. elevated INR values. A comparison to an APA-insensitive laboratory method is recommended if the presence of APAs is known or suspected.

Does the user have to run the test immediately after taking the strip out of the vial?

The open vial stability is 10 minutes maximum. Having the strip too long out of the vial, especially in situations with high humidity or temperature, would be detected by the onboard integrity system resulting in an error message. No INR would be displayed if the strips are found to be defective by the integrated quality control of the CoaguChek XS system.

What happens if the user does not change the code key?

If the incorrect code key is in the machine and you insert a test strip, a display message indicates that you need to insert the corresponding code key, otherwise a measurement will not be possible 

How does the underdosing detection work?

The fill of the capillary is detected by a current flow between two electrodes on the test strip. If the capillary is not completely filled an error message (error number 5) will appear on the display.

Is re-dosing possible if the first attempt to get enough blood was unsuccessful?

Yes, re-dosing is possible within 15 seconds. However, in principle re-dosing is very critical due to the immediate start of the coagulation process. Therefore this should be avoided if possible.

What happens if the operator applies blood before the test strip symbol and flashing drop of blood?

An error message  will appear on the screen

References

1. Guyatt et al (2012). Chest 141:7S-47S

2. Heneghan et al (2012). Lancet 379:292-293

3. Heneghan C, Alonso-Coello P, Garcia-Alamino JM, Perera R, Meats E, Glasziou P. Self-monitoring of oral anticoagulation: a systematic review and meta-analysis. Lancet 2006; 367:404-411