Overview: The document provides detailed specifications for a portable medical device designed for testing hemoglobin and hematocrit levels in whole blood. It emphasizes accuracy, convenience, and rapid testing time.
Key Features:- Testing time is less than 15 seconds with a sample volume of 10μl of whole blood.
- High memory capacity, storing up to 1000 records with date and time.
- ISO 13485 certified, ensuring compliance with international standards for medical devices.
- Three-year warranty provided by the manufacturer, Sensa Core Medical Instrumentation Pvt. Ltd.
Specifications:- Methodology: Reflectance Photometry.
- Measurement Range: 0 - 25.6 g/dL, 0 - 256 g/L, 0 - 15.9 mmol/L.
- Sample Types: Capillary, Venous, Arterial whole blood.
- Power Source: 3 AAA batteries or AC Adapter (Mini USB).
- Battery Life: 100 hours or 1000 tests.
- Automatic Shut Off: 5 minutes after last use.
- Meter Size: 100 mm × 54.5 mm × 25.5 mm; Weight: 71 g (without batteries).
- Operating Conditions: 2 - 40 ºC (35.6 - 104 ºF), 5 - 95% humidity.
Additional Capabilities:- USB Data Transfer to PC and Printer.
- Auto Calibration with sensitivity and specificity over 80%.
- Accuracy of 98% and reproducibility with CV less than 3%.
Strip Information:- Disposable strips with a working temperature of -40 ºC and humidity of 5 - 95%.
- Stable storage conditions at 2 - 40 ºC and humidity 5 - 95% with a shelf life of two years.
See more