CoaguChek® Pro II

IVD For in vitro diagnostic use.
CoaguChek<sup>®</sup> Pro II

Get immediately actionable results at all points of care

The CoaguChek® Pro II system is a clinically vital device for whole blood coagulation testing, delivering fast, reliable results when you need them most. With the ability to perform two critical assays using the CoaguChek PT Test and CoaguChek aPTT Test, this system supports timely clinical decisions across care settings:

  • Activated Partial Thromboplastin Time (aPTT): Results in under 5 minutes.
  • Prothrombin Time (PT): Results in approximately 1 minute.
A healthcare professional at the Point of Care places a test strip with a patient sample into the CoaguChek Pro II.
Benefits at a glance

Benefits at a glance

From the floors to the operating room to the A&E to the ICU, aPTT, and PT results are in your hands in real time.

  • aPTT results in less than 5 minutes.
  • PT results in approximately 1 minute.

Critical information is available when and where it is needed most.

  • Wireless connectivity and barcode reader for digital input and output
  • QR code feature enables data transmission to a data management system immediately, with no need to transcribe results for a streamlined workflow

In addition to monitoring warfarin therapy,  PT and aPTT tests will help in the determination of factor deficiencies and other coagulopathies in several Point of Care locations.

The enhanced connectivity options allow for immediate access to patient’s data via their electronic health records because wireless technology ensures fast, accurate transmission so that workflow will be more streamlined and results will be available for immediate treatment decisions.

The CoaguChek Pro II meter features

  • Detection system: electrochemical determination of the PT and aPTT time after activation of coagulation cascade
  • User interface: large color touchscreen; screen icons allow intuitive operation
  • Memory capacity: 2,000 test results
  • Integrated 2D barcode reader for entering user/patient ID and lot numbers of controls
  • Enhanced data management capabilities: WLAN and unique QR Code connectivity option
  • Universal battery pack, charging via power adapter and/or base unit *(HBU)
  • Side and top dosing options with a drop of venous, capillary or arterial fresh whole blood (min. 8 μL)

CoaguChek Pro II e-learning

For healthcare professionals using the CoaguChek Pro II meter, we offer an e-learning course to help you use the meter and get the most out of this product. At the end of the e-learning course, a short knowledge check allows you to test what you have learnt. This e-learning is complementary and open to all users of the CoaguChek Pro II meter. Roche does not store any user data of individuals taking this course. If you would like to benefit from the CoaguChek Pro II e-learning please click on the link below to get started:

 

CoaguChek Pro II e-learning

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Overview

Ordering Information

Product specification Value
Measuring and sampling
Detection system

PT: Amperometric (electrochemical) determination after activation of the blood coagulation with human recombinant thromboplastin.

aPTT: Amperometric (electrochemical) determination after activation of blood coagulation with celite.

User interface Full graphical (TFT)
Support and safety functions QC lockout, Patient and User ID, protection with administrator ID. 2D Barcode Scanner
Sample application
Outside the meter, with top-and 2 sides (left or right)-dosing options
Operating conditions***
Operating temperature +12° C to +32 °C (54 °F to 90 °F)
Operating humidity and altitude 10-85%-4300 m (14,000 ft)
Handling Operate the meter on a level, vibration free surface, or hold it so that it is roughly horizontal.
Measuring range

PT/INR: 0.8-8.0; %Q: 120-5; SEC: 9.6–96
aPTT: 20-130 plasma equivalent seconds

Memory

2000 patient and 500 QC results with date and time.

120 code chip records (60 strip code and 60 control codes)

Operator list with up to 5000 Operator IDs with corresponding 2nd ID e.g. operator name

Patient list with up to 4000 Patient IDs with corresponding

2nd and 3rd patient IDs e.g name, date of birth

Interface
Touch screen and bar code scanner
Power options

Universal battery pack for the CoaguChek Pro II

Power supply adaptor: input: 100-240 V / 50-60Hz / 350-150 mA; output: 12 V DC/ 1.25 A

Number of tests with fully charged battery pack

Approx. 60 tests-PT/INR

At least 20 tests-aPTT/measuring time 5 minutes

Dimensions 187 x 97 x 43 mm
Weight 280 g (without batteries)
Safety class III
Auto power off Programmable 1 to 60 minutes
Sample material
Sample type Capillary, venous, or arterial fresh whole blood
Sample size ≥ 8 μl
Interferences Refer to the test strip package insert
Test strips
ISI Approx. 1.0
Sensitivity to heparin

PT/INR: Insensitive to unfractionated and fractionated heparin concentrations up to 3 IU/mL blood.

aPTT: Insensitive to low molecular weight heparins (LMWH) up to 0.5 IU/mL blood.

Quality control On each strip, through the same channel as the blood passes.
Stability Store at + 2° C to + 30° C. Test strips can be used until expiry date printed on the box and test strip vial
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