Electromagnetic Compatibility; Wireless Co-Existence And Data Security - Tandem t:slim X2 User Manual

33.5 Electromagnetic Compatibility

The information contained in this
section is specific to the System. This
information provides reasonable
assurance of normal operation, but
does not guarantee such under all
conditions. If the System must be used
in close proximity with other electrical
equipment, the System should be
observed in this environment to verify
normal operation. Special precautions
for electromagnetic compatibility must
be taken when using medical electrical
equipment. The System shall be placed
into service with adherence to the EMC
information provided here. Using cables
and accessories not specified in this
user guide may adversely impact
safety, performance, and
electromagnetic compatibility, including
increased emissions and/or decreased
immunity.
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:
• Wireless Co-existence and Data
Security
• Electromagnetic Emissions
• Electromagnetic Immunity
• Distances Between the System and
RF Equipment
CHAPTER 33 • Technical Specifications
33.6 Wireless Co-existence and
Data Security
The System is designed to work safely
and effectively in the presence of
wireless devices typically found at
home, work, retail stores, and places of
leisure where daily activities occur. See
Section 33.9 Distances Between the
t:slim X2 Pump and RF Equipment
more information.
The System is designed to send and
accept Bluetooth wireless technology
communication. Communication is not
established until you enter the
appropriate credentials into your pump.
The System and system components
ensure data security via proprietary
means and ensure data integrity using
error checking processes, such as
cyclic redundancy checks.
for
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