qLabs® ElectroMeter – PT and INR Monitoring System

General Description

The qLabs® PT-INR system is designed for the quantitative measurement of prothrombin time (PT) and the international normalized ratio (INR) on fresh whole blood samples, capillary or venous.

It is intended exclusively for in vitro diagnostic use and is not indicated for screening purposes.

Operating Principle

The system consists of:

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  qLabs® ElectroMeter (electrometer)
  

  
  


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  qLabs® PT-INR Test Strips
  

  
  

The device automatically recognizes the insertion of the strip, brings it to the default operating temperature, and monitors its behavior during blood coagulation.

After applying a drop of blood, the sample is channeled into two areas: test and control, where it reacts with the pre-printed reagents.

Within each area are pairs of electrodes that detect current variations caused by the coagulation process.

The electrometer analyzes these variations to accurately determine the prothrombin time (PT) and the INR value.

Maintenance and Cleaning

Recommended Frequency:

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  After each use, especially in the presence of visible dirt or biological material
  

  
  


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  Before each use on a new patient
  

  
  


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  After excessive blood application (>20 µL)
  

  
  


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  Regularly, at least once a month
  

  
  

Areas to Clean/Disinfect:

1. 
   

   
   Strip insertion port
   

   
   


2. 
   

   Display

   
   


3. 
   

   
   Front and back casing
   

   
   


4. 
   

   Front buttons

   
   

Note: always adhere to the internal protocols of the healthcare facility for disinfection.

Conditions of Use

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  Operating Temperature: 10°C – 35°C
  

  
  


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  Relative Humidity: 10% – 90% (without condensation)
  

  
  


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  Maximum Altitude: 4300 m
  

  
  

Technical Specifications

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  Processor: ARM Cortex-M4 32 bit
  

  
  


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  Display: LCD 320 x 480 mm
  

  
  


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  Touchscreen: Capacitive
  

  
  


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  Power Supply:
  

  
  
  
  
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    External: 100–240V ~ 50/60Hz, 0.4A max
    

    
    
  
  
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    Internal: lithium battery 3.7V
    

    
    
  
  
  
  


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  Dimensions: 148 x 70 x 26 mm
  

  
  


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  Weight: 199 g
  

  
  

Classification and Codes

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  CND: W02079080
  

  
  


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  Ministerial Register: 1773492
  

  
  


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  CE Class: ST – Self-diagnostic tests (not included in Annex II)