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Additional Hospital Electronics System Functions ................................................................................................... 38
A. Wireless Connectivity Setup ................................................................................................................................................. 38
B. Setting Baseline in Follow-Up Reading ................................................................................................................................ 39
C. Settings Screen ................................................................................................................................................................... 40
D. The Admin Screen .............................................................................................................................................................. 40
Software Update ..................................................................................................................................................................... 41
Additional Patient Electronics System Functions ..................................................................................................... 41
Patient Electronics System - Viewing Pressure Values During the Reading ............................................................................... 41
Guidelines for the Management of Hemodynamic Parameters ................................................................................ 42
Elevated PA Pressures (Hyper-volemic) .................................................................................................................. 42
Low PA Pressures (Hypo-volemic) .......................................................................................................................... 43
Recommended Frequency of CardioMEMS HF System Review ............................................................................... 43
Clinical Study Information ...................................................................................................................................... 43
Introduction ............................................................................................................................................................................ 43
Purpose .................................................................................................................................................................................. 43
Methods ................................................................................................................................................................................. 43
Patient Demographics and Disposition..................................................................................................................................... 44
Primary and Secondary Endpoint Results ................................................................................................................................ 45
Results from the Entire Randomized Access Period ................................................................................................................. 46
Cleaning ................................................................................................................................................................ 62
Storage .................................................................................................................................................................. 62
User/Owner Responsibility ..................................................................................................................................... 62
Electromagnetic Interference and Electromagnetic Compatibility ............................................................................. 63
FCC Statement ...................................................................................................................................................... 65
EU REACH SVHC Disclosure .................................................................................................................................. 65
WEEE Compliance Statement ................................................................................................................................. 65
System Specifications ............................................................................................................................................ 65
Electrical Characteristics ......................................................................................................................................................... 65
Mechanical Characteristics ...................................................................................................................................................... 65
Environmental Information ...................................................................................................................................................... 66
Classification ........................................................................................................................................................................... 66
Testing .................................................................................................................................................................................... 66
EMI/EMC Testing .................................................................................................................................................................... 66
Wireless Testing ...................................................................................................................................................................... 66
Software ................................................................................................................................................................ 66
Technical Support ................................................................................................................................................. 66
Symbols ................................................................................................................................................................ 66

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