Electromagnetic Compatibility - Tandem t:slim X2 User Manual

32.5 Electromagnetic
Compatibility
The information contained in this sec-
tion is specific to the System. This infor-
mation provides reasonable assurance
of normal operation, but does not guar-
antee such under all conditions. If the
System must be used in close proximity
with other electrical equipment, the
System should be observed in this envi-
ronment to verify normal operation.
Special precautions for electromagnetic
compatibility must be taken when using
medical electrical equipment. The Sys-
tem shall be placed into service with
adherence to the EMC information pro-
vided here. Using cables and accesso-
ries not specified in this User Guide
may adversely impact safety, perfor-
mance, and electromagnetic compati-
bility, including increased emissions
and/or decreased immunity.
Customer Technical Support: (877) 801-6901
For IEC 60601-1 testing, Essential
Performance for the System is
defined as follows:
• The System will not over deliver a
clinically significant amount of
insulin.
• The System will not under deliver a
clinically significant amount of
insulin without notification to the
user.
• The System will not deliver a
clinically significant amount of
insulin after occlusion release.
• The System will not discontinue
reporting CGM data without
notification to the user.
This section contains the following
tables of information:
• Electromagnetic Emissions
• Electromagnetic Immunity
• Distances Between the System and
RF Equipment
Chapter 32 – Technical Specifications
283