Nipro 4Sure Smart Duo, Owner'S Manual

EN-2

2. Important Information

• Severe dehydration and excessive water loss may cause readings which are lower 

than actual values. If you believe you are suffering from severe dehydration, consult a 

healthcare professional immediately.

• If your blood glucose or β-Ketone results are lower or higher than usual, and you 

do not have symptoms of illness, first repeat the test. If you have symptoms or 

continue to get results higher or lower than usual, follow the treatment advice of your 

healthcare professional.

• Use only fresh whole blood sample to test your blood glucose or β-Ketone. Using 

other substances will lead to incorrect results.

• If you are experiencing symptoms that are inconsistent with your blood glucose or 

β-Ketone test results and you have followed all instructions described in this owner’s 

manual, call your healthcare professional.

• We do not recommend using this product on severely hypotensive individuals 

or patients in shock. Readings which are lower than actual values may occur for 

individuals experiencing a hyperglycaemic-hyperosmolar state, with or without 

ketosis. Please consult the healthcare professional before use.

3. Introduction

Intended Use

This system is intended for use outside the body (

in vitro 

diagnostic use) by people 

with diabetes at home and by health care professionals in clinical settings as an aid 

to monitor the effectiveness of diabetes control. It is intended to be used for the 

quantitative measurement of glucose (sugar) and β-hydroxybutyrate (Ketone) in fresh 

whole blood samples with following indications.
Home use of blood glucose testing requires capillary blood samples from fingertip 

or alternate sites (AST) palm, forearm and upper arm. In addition, health care 

professionals may also use arterial and venous blood samples, as well as neonatal 

blood from the heel. 
For professional use of blood glucose testing, only use heparin for anticoagulation of 

arterial, venous and capillary whole blood samples.
Home use of β-Ketone testing requires capillary blood samples from the fingertip only. 

(Alternate site testing is not supported). In addition, health care professionals can also 

use venous blood samples, however arterial, neonatal and alternate site testing is not 

supported.  
For professional use of β-Ketone testing, only use heparin for anticoagulation of 

venous and capillary whole blood samples.
This system is not intended for use in the diagnosis or screening of diabetes mellitus.