LabStyle Dario User Manual - Intended Use
Glucose Monitoring for a Mobile Age
Chapter 1 - Introduction & User Safety
1
ChApter 1 – IntrodUCtIon & USer SAfety
GlUCoSe MonItorInG for A MobIle AGe
Congratulations on your choice of the Dario™ Blood Glucose Monitoring System
(BGMS). Dario™ was created to make life easier for people with diabetes - with
the right tools, information and support in your pocket. It is a smartphone-based
monitoring system, featuring a pocket-sized meter with an integrated lancing
device and test strips, combined with an easy-to-use mobile application.
Living with diabetes is a daily challenge. But with Dario™ in your pocket and the
best support, we can thrive with diabetes together.
This user guide will guide you through the proper setup and use of your new Dario™
BGMS. We suggest that you read this guide thoroughly in order to familiarize
yourself with the system and its many features
Intended USe
The Dario™ BGMS is intended for determination of blood glucose values using
fresh capillary whole blood from the fingertip.
The Dario™ BGMS is indicated for the quantitative measurement of glucose in fresh
capillary whole blood samples drawn from the fingertips.
The system is intended to be used by a single patient and should not be shared.
The Dario™ BGMS is intended for self-testing outside the body (in vitro diagnostic
use) by people with diabetes at home as an aid in monitoring the effectiveness of
diabetes control.
The Dario™ BGMS is not to be used for the diagnosis of or screening of diabetes or
for neonatal use.
The Dario™ Blood Glucose Meter (BGM)
must be used with Dario™ blood glucose
test strip, Dario™ control solutions, Dario™ lancets and Dario™ application
software.