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CoaguChek® Pro II

Expanding coagulation testing in the hospital point of care setting

Product image for CoaguChek ® Pro II

Get immediately actionable results at all points of care

CoaguChek®Pro II system is the clinically vital point-of-care coagulation testing device.

CoaguChek® Pro II - Key Statement
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Expanding coagulation testing in the hospital point of care setting

In addition to monitoring warfarin therapy, the prothrombin time (PT) and activated partial prothrombin time (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 patients’ 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.

CoaguChek Pro II

The CoaguChek Pro II meter features

  • Detection system: electrochemical determination of the PT and aPTT time after activation of coagulation cascade
  • User interface: large TFT 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
    CoaguChek Pro II WLAN Addendum
  • 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)

 

Clinically vital

 

  • From the floors to the OR to the ER to the ICU, aPTT and PT results are in your hands in real time

 

Enhanced connectivity

 

  • Critical information is available when and where it is needed most
  • Wireless connectivity and bar code reader for digital input and output
  • QR code feature enables data transmission to any data management system immediately, with no need to transcribe results for a streamlined workflow
CoaguChek Pro II

Determine 2 assays with the CoaguChek Pro II meter

Activated partial thromboplastin time (aPTT) with results in less than 5 minutes and prothrombin time (PT) (with extended claims) with results in approximately 1 minute

System components

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

 

Optional components

 

  • Handheld base unit kit: docking station (to recharge the battery pack and transfer data to a computer)

 

Additional required components

 

  • CoaguChek PT Test strips Box with 2 vials of 24 strips with a code chip
  • CoaguChek aPTT Test strips Box with 2 vials of 24 strips with a code chip
  • CoaguChek PT Controls 4 vials of level 1 control, 4 vials of level 2 control, 8 diluent-filled droppers, 1 code chip
  • CoaguChek aPTT Controls 4 vials of level 1 control, 4 vials of level 2 control, 8 diluent-filled droppers, 1 code chip

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Technical specifications

Technical specifications

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 & 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 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 & 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 3rdpatient 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 adapter: input: 100-240 V / 50-60Hz / 350-150 mA; output: 12 V DC/ 1.25 A

 

Number of tests w/ 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 type
 

Capillary, venous, or arterial fresh whole blood

 

Sample size
 

≥ 8 μl

 

Interferences
 

Refer to the test strip package insert

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.