User's Guide
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5. Classication and Compliance with Standards
• The Diabecare DANA-i is classified as an internal powered equipment BF type under
the standard of IEC 60601-1
(Medical Electrical Equipment, General Requirements for Safety).
• It is not suitable for use in the presence of a flammable anesthetic mixture by the
standard of IEC 60601-1.
• The System will continuously operate according to the user defined settings.
6. Essential Performance
The Insulin infusion pump maintains insulin delivery accuracy in the specified environmental conditions.
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