Prodigy Mini-Mist - Performance Standards

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Prodigy Diabetes Care, LLC 1.800.243.2636
PRODIGY Mini-Mist
™
Owner’s Manual
Specifications
Performance Characteristics
Thequalityofthedevicehasbeenveriedandisinline
with the provisions of the EC council directive 93/42/
EEC (EN IEC60601-1 General requirements for safety,
EN IEC60601-1-2: 2001 Electromagnetic compatibility
requirements and tests) date dated 14 June 1993
concerning medical devices and the EN performance
standards as follow:
EN 13544-1 2007: Respiratory therapy equipment-
part1 ; nebulizing systems and their
components.