Test Principle And Performance - Infopia EASYGLUCO Auto-coding Operation Manual

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Table Of Contents

Table of Contents

Troubleshooting

Problem

Caused by

The meter does not

Batteries are dead or

power on

there is a problem with

the meter

Test does not start

Poor amount of blood

after applying blood

sample

The result is

There may be a problem

inconsistent

with the test strip

Coding failure

What to do

Change the battery and if the

problem persist, contact your

local representative.

Please insert a new test strip,

and perform your test again,

applying sufficient amount of

blood sample.

Please insert a new test strip,

and perform your test again.

Confirm that the code on the

meter matches with the code on

the test strip vial. If the code

does not match, contact your

local representative.

Measurement Range :

The measurement range of the EASYGLUCO Auto-coding

600 mg/dL (0.6 - 33.3 mmol/L).

Test Principle :

Glucose in the blood sample will react to the electrodes in the test strip,

generating an electrical current that will stimulate a chemical reaction. This

reaction is measured by the EASYGLUCO Auto-coding

as your blood glucose result.

Note: Different levels of reactions will occur depending on the amount of

glucose in the blood sample.

Calibration :

The EASYGLUCO Auto-coding

comparison of results with laboratory methods.

Accuracy :

Studies have shown that the test results of EASYGLUCO Auto-coding

compare well with laboratory methods.

Precision :

The precision of EASYGLUCO Auto-coding

studies in accordance with ISO 15197.

Results for venous blood samples and Control solutions :

Blood

43 mg/dL 2,39 mmol/L SD = 1.4

Blood

91 mg/dL 5,05 mmol/L SD = 2.2

Within Run Precision

Blood

145 mg/dL 8,05 mmol/L SD = 4.2

Blood

223 mg/dL 12,38 mmol/L SD = 7.7

Blood

360 mg/dL 19,98 mmol/L SD = 6.4

Control

41 mg/dL 2,28 mmol/L SD = 1.5

Total Precision

Control

113 mg/dL 6,27 mmol/L SD = 3.0

Control

328 mg/dL 18,20 mmol/L SD = 9.3