BIONIME Rightest GM300 Manual do Utilizador descarregar pdf (Página 2)

- Healthcare professionals should evaluate their technique and their patients' technique at periodic

intervals. To accomplish this, it is recommended that BGM results be compared with a concurrently

obtained laboratory measurement on the same blood sample. A well characterized clinical

laboratory method employing hexokinase or glucose oxidase should be used as the comparative

method.

- Fluoride should not be used as a preservation for venous specimens when using blood glucose

monitors.

- Hands and fingers contaminated with sugar from foods or beverages may cause falsely elevated

results.

- Differences in whole blood and serum/plasma values may cause variability in results.

- Storage of strips near bleach as well as bleach containing products will affect results of glucose

oxidase strips.

- The use of cellular phones and other radio transmitting devices should be prohibited in areas where

testing occurs.

- Rightest™ Blood Glucose Test Strips are designed for use with capillary whole blood samples.

Do not use serum or plasma samples.

- Incorrect test results may be obtained at high altitude more than about 10000 feet (3048 meters)

above sea level.

- Hematocrits below 30% may cause higher results, and hematocrits above 55% may cause lower

results.

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

- Rightest™ Blood Glucose Monitoring System has not been validated for use on neonates.

Therefore, it should not be used for neonates.

- Do not perform the blood glucose test at temperatures below 10 (50 ) or above 40 (104 ),

below 10% or above 90% relative humidity.

Storage and Handling

- Store the strips in the original capped vial at temperatures between 4 to 30 (39 to 86 ) and

relative humidity below 90%. Do not freeze.

- Replace the vial cap immediately and close tightly after taking test strip out from the vial. Do not

leave the cap of vial opened. If the strip is exposed in the air too long, it will absorb the moisture and

cause wrong test result.

- Use test strips within 3 months after first opening.

Measurement Range

The measurement range of the Rightest™ System is 10 to 600 mg/dL or 0.6 to 33.3 mmol/L.

Quality Control Section

Please refer to the Quality Control section of the User Manual.

Accuracy

The accuracy of the test study of the Rightest™ 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 176 patients were enrolled. Each patient collected and tested their own blood samples (from the

fingertip) using the Rightest™ Meter. Another blood sample was collected within 5 minutes and got the

plasma to be analyzed on the lab instrument. Ninety-seven percent of the results were within +/- 20% of the

comparison method results at glucose concentrations ≧ 75 mg/dL and within +/-15 mg/dL at glucose

concentrations <75 mg/dL.

Troubleshooting and Customer Service

For more information on error messages and trouble shooting, please refer to the Error Messages

and Trouble Shooting section of the Rightest™ User manual.

You may also contact customer service by calling 886 4 24951268 ( 08:30 - 17:30, GMT + 08:00 ).

( At all other times, you could contact your healthcare professional for assistance )

℃ ℉ ℃ ℉

℃ ℃ ℉

Interferences

The following compounds may interfere with the glucose

measurement at the concentrations listed:

Uric acid > 0.54 mmol/L (> 9.0 mg/dL)

L -Dopa > 0.076 mmol/L (> 1.5 mg/dL)

Methyldopa > 0.071 mmol/L (> 1.5 mg/dL)

Cholesterol > 6.5 mmol/L (> 250 mg/dL)

Reagents

Each Blood Glucose Test Strip contains the following

reagents:

Glucose Oxidase (Aspergillus niger) (GOD) 8.5 %

Potassium ferricyanide 48.5 %

Non-reactive ingredients 43 %

References

1) Consensus statement on self monitoring of blood glucose. Diabetes Care 1987; 1:95-99.

2) Diabetes Information - American Diabetes Association and National Institute of Diabetes and

Digestive and Kidney Diseases ( NIDDK )

Store between tempe rature 4 and 30 ( 39 and 86 ) ℃ ℃ ℉ ℉

For in vitro diagnostic use

Manufacturer

LOT

IVD

Lot number

Use by

101-3GS300-034

EN

BIONIME CORPORATION

694, Renhua Road, Dali City,

Taichung County, Taiwan 412

Tel: +886 4 24951268 Fax: +886 4 24952568

E-mail: [email protected] http://www.bionime.com

EU Representative:

BIONIME GmbH

Heinrich Wild Strasse 202,

CH-9435 Heerbrugg

Switzerland

Accuracy

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 176 patients were enrolled. Each patient collected and tested their own blood samples ( from

the fingertip ) using the Rightest™ Meter. Another blood sample was collected within 5 minutes and got

the plasma to be analyzed on the lab instrument.

Linearity regression produced the following line equation (Lab instrument-YSI 2300D was considered to

be the reference method):

Rightest™

Patient

Rightest™ fingertip vs YSI-Plasma

Test range

Test number

Slope

Intercept (mg/dL)

r

30~572 mg/dL (1.7~31.8 mmol/L)

176

1.03

-0.25

0.9911

0

50

100

150

200

250

300

350

400

450

500

550

600

0 50 100 150 200 250 300 350 400 450 500 550 600

N=176

Slope=1.03

Intercept=-0.25

r=0.9911

YSI (mg/dL)

Patient

Fingerstick (mg/dL)

E

D

B

B

D

C

C

E

A

A

Additional Information for Healthcare Professionals

Detection Principle

The glucose oxidase and potassium ferrocyanide in the strip react with the glucose in the sample to

produce an electrical current which is proportional to the amount of glucose in the sample. The meter

measures the current and converts it to the corresponding glucose concentration.

Performance Characteristics

Measurement Range

The measurement range of the Rightest™ System is 10 to 600 mg/dL or 0.6 to 33.3 mmol/L.

Precision

The precision was evaluated including (i) venous whole blood sample (ii) 3 levels glucose control

solution in period of 20 days, by 10 meters and 1 batch of strip.

(ii) Control solution:

P-01

100

40.6(2.3)

1.5(0.08)

3.6%

P-02

100

96.9(5.4)

2.5(0.14)

2.6%

P-03

100

117.3(6.5)

2.5(0.14)

2.1%

P-04

100

192.9(10.7)

3.9(0.22)

2.0%

P-05

100

351.5(19.5)

6.3(0.35)

1.8%

CS-L

100

50.5(2.3)

1.2(0.06)

2.5%

CS-N

100

102.2(5.8)

2.0(0.11)

1.9%

CS-H

100

302.3(16.7)

6.6(0.36)

2.2%

(i) Venous whole blood sample:

Glucose levels

(1) Total test numbers (n)

(2) Mean mg/dL (mmol/ L)

(3) SD mg/dL (mmol/ L)

(4) CV (%)

Meters

(1) Total test numbers (n)

(2) Mean mg/dL (mmol/ L)

(3) SD mg/dL (mmol/ L)

(4) CV (%)

1 2

Comentários a estes Manuais

ChrisTom 17 Apr 2024 | 22:41:43

Hello, im noob :)