Description

The CoaguChek Pro II Kit by Roche Diagnostics is a sophisticated in vitro diagnostic device designed for healthcare professionals. It provides reliable point-of-care testing for blood coagulation, specifically performing Prothrombin Time (PT/INR) and Activated Partial Thromboplastin Time (aPTT) assays. This device is particularly beneficial for monitoring patients undergoing Vitamin K Antagonist (VKA) therapy, making it ideal for use in hospitals, anticoagulation clinics, and doctor’s offices.

Key Features

• Rapid Results: The device delivers PT/INR results in approximately one minute and aPTT results in less than five minutes, using capillary, venous, or arterial whole blood samples.
• Minimal Sample Requirement: Requires a small sample volume of just 8 μL, enhancing convenience and efficiency.
• Advanced Detection: Utilizes amperometric electrochemical determination with specific activation methods for accurate results.

Test Strip Specifications

• Insensitive to Heparin: PT/INR test strips are insensitive to heparin up to 3 IU/mL, and aPTT strips to LMWH up to 0.5 IU/mL.
• On-Strip Quality Control: Includes a code chip for calibration and lot identification, ensuring precise and reliable measurements.

User Interface and Connectivity

• Touchscreen Display: Features a full graphical TFT touchscreen for intuitive operation.
• Data Management: Equipped with a 2D barcode scanner and QR code functionality for seamless data transmission.
• Wireless Connectivity: Offers WLAN capabilities, storing up to 2000 patient results and extensive operator and patient ID records.

Power and Portability

• Versatile Power Options: Comes with a rechargeable battery pack and power supply adapter, allowing for flexible use.
• Compact Design: Weighs 280 g and measures 187 x 97 x 43 mm, suitable for handheld use or placement on a stable surface.

Environmental Conditions

• Operating Range: Functions effectively within temperatures of +12°C to +32°C and up to 4300 m altitude.
• Test Strip Storage: Strips remain stable between +2°C and +30°C until their expiry date.

Security and Compliance

• Medical Device Classification: Classified as a Class III medical device with stringent compliance features such as password protection and mandatory quality control lockouts.
• User Training: Requires training and competency assessment for all operators, ensuring safe and effective use.

Maintenance

• Cleaning Protocols: The device should be cleaned with alcohol or bleach solutions, avoiding immersion and direct spraying. The test strip guide can be cleaned with isopropanol or ethanol.

Kit Contents

The kit includes the CoaguChek Pro II instrument, a handheld power supply unit, and a comprehensive user manual available in multiple languages. Note that test strips are not included in the kit.

This device is not intended for home use or self-testing, and its features may vary based on country-specific configurations. The CoaguChek Pro II Kit stands out as a robust solution for healthcare providers seeking accurate and efficient coagulation testing at the point of care.