OKmeter Blood Glucose Monitoring System

Product catalog summary

Overview: The document provides detailed information about a blood glucose monitoring system that requires no coding and supports alternative site testing. The system is designed for quick and accurate blood glucose measurement.

Key Features:

Accurate results in 6 seconds.
Requires a very small blood sample of only 0.7 μL.
Memory capacity for 250 tests with date and time.
Risk indicators for glucose levels lower than 70 mg/dL or higher than 180 mg/dL.
PC download capability.

Specifications:

Measurement Range: 20-600 mg/dL (1.1-33.3 mmol/L).
Sample Type: Capillary Whole Blood.
Alternative Site Testing: Available (palm, forearm, upper arm, calf, and thigh).
Calibration: Plasma-Equivalent.
Test Time: 6 seconds.
Sample Volume: 0.7 μL.
Operating Condition: 10-40 °C (50-104°F), 10-85% R.H.
Storage Condition: 4-40 °C (39-104°F), 10-85% R.H.
Memory Capacity: 250 tests with time and date.
Risk Indicator: Alerts for tests within 70-120 mg/dL and outside 70 mg/dL or 180 mg/dL.
Average: 7, 15, and 30 days.
Downloadable: RS-232.
Battery Type: 3V Li-Battery (CR 2032) X1.
Battery Life: 1,000 tests.
Meter Dimensions: 93 X 53 X 15 mm.
Meter Weight: 50g (including battery).
Expiration for test strips: Storage - 24 months, In use - 180 days.

Compliance and Accuracy:

Manufacturer: OK Biotech Co., Ltd., Taiwan.
Certifications: ISO 13485, CE 0123, ISO 14001.
System Accuracy: Complies with ISO 15197 Standard, with 95.5% of results meeting the requirements.

System Accuracy Results:

For glucose concentration < 4.2 mmol/L (75 mg/dL): Within ± 0.83 mmol/L (15 mg/dL) for 18% of tests, and within ± 0.28 mmol/L (5 mg/dL) for 83% of tests.
For glucose concentration ≥ 4.2 mmol/L (75 mg/dL): Within ± 15% for 34% of tests, and within ± 5% for 99% of tests.
Combined accuracy results show 95.5% compliance with ISO standards.

Graphical Data: A scatter plot with Passing & Bablok fit demonstrates the correlation between the OKmeter and the reference system YSI2300, indicating high accuracy and reliability.

Catalog excerpts

OKmeter Blood Glucose Monitoring System-1

Blood Glucose Monitoring System Alternative Site Testing Insert test strip to turn on meter. •Accurate results in 6 seconds •Very small blood sample, only 0.7 μL •250 test memory with date and time •Risk Indicators for lower than 70 mg/dL or higher than 180 mg/dL Apply small blood sample. Obtain results in 6 seconds.

Open the catalog to page 1

OKmeter 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 < 4.2 mmol/L (75 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 > = 4.2 mmol/L (75 mg/dL) Within ± 5 % 54 / 160 (34 %) CE 0123 ISO 13485 OK Biotech Co., Ltd. 4F-1, No. 83, Sec. 2, Gongdao 5th Rd., 300 Hsinchu...

Open the catalog to page 2

OKmeter Blood Glucose Monitoring System

OKmeter Blood Glucose Monitoring System

Catalog excerpts

All OK Biotech catalogs and technical brochures