OKmeter Hitech II Blood Glucose Monitoring System

Product catalog summary

Overview: The document provides detailed specifications and performance data for the OK-7W Blood Glucose Monitoring System by OK Biotech Co., Ltd. It highlights the device's portability, accuracy, and alternative site testing capabilities.

Specifications:

Model Name: OK-7W
Assay Method: Electrochemical biosensor
Test Sample: Capillary whole blood
Sample Size: 0.7 μL
Measuring Time: 5 seconds
Measuring Range: 20 – 600 mg/dL (1.1 – 33.3 mmol/L)
Acceptable Hematocrit Range: 20~60%
Operating Conditions: 5°C~45°C (41°F~113°F), 10~85% R.H.
Storage/Transportation Conditions: 4°C~45°C (39°F~113°F), 10~85% R.H.
Memory Capacity: 1 test result
Power Supply: One 3-volt Lithium Battery (CR2032)
Battery Life: Approximately 1,000 tests
Automatic Shut-off: In 5 minutes
Dimensions: 48 mm (L) × 48 mm (W) × 40 mm (H)
Weight: 24 g including battery

Performance and Accuracy:

The system complies with ISO 15197:2013 standards.
For glucose concentrations < 5.6 mmol/L (100 mg/dL), 90% of results are within ± 0.28 mmol/L (± 5 mg/dL).
For glucose concentrations ≥ 5.6 mmol/L (100 mg/dL), 95% of results meet the accuracy requirements.
For glucose concentrations between 2.1 mmol/L (37.5 mg/dL) and 29.3 mmol/L (527 mg/dL), 100% are within ± 5%, and 80% are within ± 15%.

Alternative Site Testing: The device supports testing on the palm, forearm, upper arm, calf, and thigh, providing flexibility for users.

Certifications: The device is certified under ISO 13485, CE 0123, and GMP standards, ensuring quality and safety.

Contact Information: OK Biotech Co., Ltd., No. 91, Sec. 2, Gongdao 5th Rd., Hsinchu City 30070, Taiwan. TEL: +886-3-5160258, FAX: +886-3-5160028, www.okbiotech.com, Email: [email protected]

Catalog excerpts

OKmeter Hitech II Blood Glucose Monitoring System-1

Blood Glucose Monitoring System Insert test strip to turn on meter. Alternative Site Testing mg/dL Easy to carry with strips Apply small blood sample. ‧Accurate results in 5 seconds ‧Very small blood sample, only 0.7 µL ‧Alternate site testing mg/dL Obtain results in 5 seco

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OKmeter Hitech II Blood Glucose Monitoring System-2

Test system: OKmeter Reference system: YSI2300 Sample: Whole blood (capillary) Investigative Site: Institut für Diabetes-Technologie GmbH an der Universität Ulm (IDT) Helmholtzstrasse 20, D-89081 Ulm / Germany System accuracy results for glucose concentration < 5.6 mmol/L (100 mg/dL) Within ± 0.28 mmol/L (Within ± 5 mg/dL) Within ± 0.56 mmol/L (Within ±10 mg/dL) Within ± 0.83 mmol/L (Within ± 15 mg/dL) System accuracy results for glucose concentration > = 5.6 mmol/L (100 mg/dL) System accuracy results for glucose concentrations between 2.1 mmol/L (37.5 mg/dL) and 29.3 mmol/L (527 mg/dL) Within...

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OKmeter Hitech II Blood Glucose Monitoring System

OKmeter Hitech II Blood Glucose Monitoring System

Catalog excerpts

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