User's Manual

Regulatory Information 25
2net Regulatory Information
Intended Use Statement
The 2net Hub is used in the Qualcomm Life Platform to capture and
transmit medical device data. The 2net Hub is intended to receive,
convert (from one format to another), store and transfer data from
a connected medical device and to act as a medical device data
system (MDDS). The 2net Hub transfers the data wirelessly, via
either WiFi or cellular network, to the Qualcomm Life Platform. The
2net Hub performs these functions without controlling or altering
the function or parameters of any connected medical devices.
The transfer of data from the 2net Hub is subject to time delays and
potential data loss due to conditions in which the 2net Hub and the
Qualcomm Life Platform are operating, including: network or power
disruptions, connectivity interruptions, medical and mobile device
limitations and user error, time zone osets, and other conditions
outside the control of the 2net Hub or the Qualcomm Life Platform.
The 2net Hub is not to be relied upon for transmitting data
necessary to inform immediate medical decisions, for transmitting
continuously (24/7 or similar), for the time-sensitive monitoring of a
patient, or for connecting to emergency response systems.
Wireless Devices
The Hub contains radio transmitters and uses non-ionizing
radio frequencies (“RF”). The Hub operates within the exposure
limits for an uncontrolled environment as set by the U.S. Federal
Communications Commission (“FCC”) and Innovation and Science
and Economic Development Canada (“ISED”). The 2net Hub should
be installed and operated with a minimum distance of 8 inches (20
cm) between the radiator (Hub) and any person.
Scientific research on wireless devices and RF energy has been
conducted worldwide for many years, and continues. In the United
States, the Food and Drug Administration (“FDA”) and the FCC
set standards and regulations pertaining to wireless devices. The