CoaguChek® XS Pro system

Coagulation monitoring for healthcare professionals

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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.

 

Greater convenience

 

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

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. 

System components

  • 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

 

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)

 

Additional required components

 

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 international 1 level CoaguChek XS PT-control kit including:

  • 4 vials with a concentration of ~ 2.0 INR
  • 4 diluent-filled droppers
  • 1 code chip
  • Package insert

References

 

  1. Roche Diagnostics, operators manual CoaguChek XS Pro system, 2015.

Technical specifications

Technical specifications

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 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 lists with up to 5000 Operator IDs with corresponding 2nd ID.
  • Patient lists with up to 4000 Patient IDs with corresponding 2nd and 3rd patient IDs.

 

Interface
 

Infrared interface

 

Power options
 

  • Power supply adaptor: input: 100 - 240 V / 50 - 60Hz / 400mA; 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 type
 

Fresh capillary whole blood or non - anticoagulated venous 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)