User Manual

68
(Electronic Protected Health Information), Labstyle Innovation has performed a
risk analysis and has implemented the standard and applicable security
safeguards and is compliance with the HIPAA Security Rule and HITECH Act
requirements for breach notification. Labstyle Innovation ongoing compliance
program includes policies and procedures for secure cloud operations.
Labstyle Innovation uses commercially reasonable standards of technology and
operational security to protect users’ glucose measurements data within the
Dario App and cloud servers. Users data is stored and transmitted through the
Dario App and/or web portal to and from the remote server in encrypted form.
Compliance with Electrical and Safety Standards
The Dario LC Blood Glucose Meter has been tested for:
• Electrostatic discharge as specified in IEC 61000-4-2.
• Immunity to radio frequency interference at the frequency range
and test levels specified in IEC 61000-4-3.
• EMC and is in compliance with IEC 60601-1-2.
• Electro-magnetic emission requirements as per EN 61326
Disposing of Used Products
The product may come into contact with blood during measurement. Used
products (i.e., test strips and lancets) therefore carry a risk of infection.
Please dispose of used products according to the regulations applicable in your
country. For information about correct disposal, please contact your health
care provider or your local council/authority.
The product falls outside the scope of the European Directive 2002/96/EC
(Directive on waste electrical and electronic equipment (WEEE)).