Sensolite Nova Bedienungsanleitung PDF herunterladen

Test strips for quantitative measurement of glucose concentration

in whole blood using with the SensoLite Nova and

SensoLite Nova Plus blood glucose meter.

Before you begin

Carefully read this entire guide. If you have any question

and/or need assistance, please, contact our authorised

distributor in your country.

Summary

SensoLite Nova blood glucose test strip was designed to

provide an easy, accurate method for the determination of

capillary whole blood glucose content. This analysis applies

the enzyme glucose oxidase and is based on advanced

electromechanical technology that is specific for ß-D-glucose

measurement. Test strips are designed in such a way that

blood sample absorbs into the reaction zone, after blood has

been applied to the tip of test strip. In the reagent zone glucose

oxidase triggers the oxidation of glucose in blood. Intensity of

formed electrons is measured by the meter and correlates

well with the concentration of glucose in the blood sample.

Package contents

• 10, 25 or 50 strips in a vial

• Code-card

• Instructions for use

Measuring range

Measurement range of SensoLite Nova Test System is

1.1-33.3 mmol/l (20-600 mg/dl).

Sample volume

One blood drop is enough to determine blood glucose value with

SensoLite Nova Test strip. Minimum sample volume is 0.5 μl.

Reagents

Each test strip contains the following ingredients in the

approximate concentrations listed below:

• Glucose oxidase 2.7 I.U.

• Hexaamineruthenium(III)chloride 45.7μg

• Other ingredients 1.6 μg

Each vial cap contains 2-3 g silica gel.

Warnings and precautions

SensoLite Nova Test blood glucose strips are for

IN VITRO diagnostic use only (external use only).

• Do not use test strips after their expiration date.

• Do not use test strips that are wet, bent, scratched,

or damaged in any way.

• Do not re-use the strips.

• If you have symptoms which are not consistent with your

blood test results always contact your health care professional

immediately.

• If your reading result is above or below your expected

range of blood glucose values, always repeat the test

and prove that the values are consistent.

• Abnormal red blood cell quantity (hematocrit below 30% or

above 55%) may cause incorrect results.

• Never make significant changes in your diabetes treatment

program or ignore symptoms without consulting your

physician.

• You must calibrate (code) the meter before the first use of

the system or when a new box of test strips is to be used.

SensoLite Nova and SensoLite Nova Plus systems use

internal coding system. A Code-card, being included in

the test strip package, holds encoded alfanumerical infor-

mation that matches the Code value being affixed to

the bottle of test strips. Setting the code in the meter

means entering the same code value into SensoLite Nova

glucose meter that is written on the strips’ bottle

label whenever you open a new bottle of test strips

(either by using the Code-card, or manually). The code

value entered into the meter should match the code value

indicated on the strip bottle’s label and being encoded on

Code-card. On how to enter the code number refer to the

chapter „Strip code setting” in the Instructions for Use of

Sensolite Nova and Sensolite Nova Plus glucose meters.

Storage and Handling

SensoLite Nova Test blood glucose strips are packaged in

bottles. Store test strips at temperature between 8°C and

30°C (47°F-and 86°F) and between 30-70% relative humidity

and far from direct sunlight. Do not refrigerate or freeze. When

stored properly, the unopened test strips are stable until the

expiration date, indicated on the bottle. The month indicated,

refers to the END of that month. Use the strips within

3 months after first opening of their bottles. Never touch the

test strips with wet or contaminated hands.

Sample collection and preparation

Preparation

SensoLite Nova Test blood glucose strips are designed

specifically for use with fresh capillary whole blood taken from

fingertip or earlobe. Venous blood, plasma, or serum samples

cannot be used. Blood testing must be performed immediately

after the sample is obtained. Common anticoagulants and

preservatives such as heparine and sodium EDTA are allowed

to be used, but fluoride preservatives should be avoided.

Testing your blood

Refer to information described in chapter „Measuring with the

meter” of the Instructions for Use of the SensoLite Nova and

SensoLite Nova Plus meters.

Used strip and lancet are contaminated with

blood. Be careful, follow the relevant, local

instructions when you throw the used strip and

lancet away.

Quality Control

It is recommended to run the quality control test in (see

“SensoLite Nova and SensoLite Nova Plus system checking”

chapter in instruction for use) cases:

• When your test results do not agree with your expectation

based on your actual feeling.

• When the test strips have been exposed to temperature,

not conforming to prescribed storage conditions (8°C to

30°C or 47°F to 86°F).

• When you open a new bottle of test strips.

• If the meter has been dropped.

• At least once per week to verify that the meter and test

strips are working properly together.

When using Control Solution for system checking apply only

CareSens Control Solution, designed specifically for this

system. CareSens Control Solution can be obtained from

Manufacturer upon user’s request for additional charge (see

exact address and phone number of manufacturer at the end

of this manual). Other control fluids provide incorrect results,

therefore cannot be used. When control solutions are used,

test results should be within the expected range indicated on

test strips bottle (L1, L2). Test results being within the given

range, indicate that the system (your meter and test strips) is

working properly. If test results obtained with control solution

are not within the indicated range, always repeat the control

solution test. If the incorrect result still stands, contact your

local distributor.

Blood Glucose Test Strip

0197

SensoLite Nova Test

1 2

Inhaltsverzeichnis

Seite 1 - SensoLite Nova Test

Test strips for quantitative measurement of glucose concentrationin whole blood using with the SensoLite Nova andSensoLite Nova Plus blood glucose met

Seite 2 - CV (%) 4.1 3.75 3.2 3.1 4.0

Test resultsBlood glucose test results are shown on the meter's LCDdisplay in either mg/dl or mmol/l measurement unit. Units canbe set prior the

Kommentare zu diesen Handbüchern

Keine Kommentare

Sensolite Nova Bedienungsanleitung

Stöbern Sie online oder laden Sie Bedienungsanleitung nach Nein Sensolite Nova herunter. SensoLite Nova Test user manual [en] Benutzerhandbuch

Inhaltsverzeichnis

Kommentare zu diesen Handbüchern