BIONIME GM550 Manual do Utilizador descarregar pdf (Página 24)

- BGMS is not intended for serum or plasma test.

- Inaccurate test results may be obtained at high altitude more than about 3048 meters (10,000 feet)

above sea level.

- Severe dehydration and excessive water loss may cause inaccurately low results.

- BGMS has not been validated for use on neonates.

- The glucose test may be interfered under abnormal concentration of

Uric acid > ( > )

Rightest GM550

16 mg/dL 0.96 mmol/L

AccuracyLimitations

NOTE

- Suggest not to use this meter close to source of strong electromagnetic radiation, to avoid

interference with proper operation.

- Suggest to keep meter free of dust, water or any liquid.

Traceability calibration:

We use YSI 2300 STAT Plus™ Analyzer as the measurement reference. The YSI 2300 STAT Plus™

Analyzer was calibrated by YSI 2747 Standard solution and can be traced to NIST Standard

Reference Material 917c, D-Glucose (Dextrose).

Type sample calibration:

The type sample used for calibration is blood.

The accuracy of the test study of the Blood Glucose Meter was demonstrated by

comparing whole blood (plasma equivalent) glucose values on the Rightest™ meter with plasma

glucose values on a lab instrument.

A total of 114 patients were enrolled. Each patient collected and tested their own blood samples

(from the fingertip, ) using the Rightest™ . Another blood sample was

collected within 5 minutes and got the plasma.

Rightest™

palm and forearm System

Analyze the plasma by the lab instrument - Olympus

AU640. Ninety-seven percent of meter values were within ± 20% of the Olympus values

at glucose concentrations ≧75 mg/dL and within ±15 mg/dL at glucose concentrations＜75 mg/dL.

The results and differences between the two methods, System and Olympus AU640 (as

the reference method) are proved in the tables below.

Difference range in values

between the Olympus value

and the Rightest™ meter

value

Within ± 5 mg/dL

Within ± 10 mg/dL

Within ± 15 mg/dL

The percent ( and number ) of samples for which the difference between the

Rightest™ meter value and the Olympus value were within the difference range

shown in the side row.

Table 1: represents samples for glucose results lower than 75 mg/dL.

Fingertip

78.9% (15/19)

100% (19/19)

Palm

78.9% (15/19)

94.7% (18/19)

100% (19/19)

Forearm

42.1% (8/19)

78.9% (15/19)

94.7% (18/19)

1 2 ... 19 20 21 22 23 24 25 26

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