User's Guide
Table Of Contents
- 1 Tips for Reading and Understanding this User Guide
- 2 Before you Begin Using Bigfoot Unity
- 3 Indications and Safety Information
- 4 Bigfoot Unity Welcome Kit
- 5 First Time Setup of Bigfoot Unity
- 6 Using Bigfoot Unity Caps
- 6.1 Pairing the Black and White Caps
- 6.2 Using the Black and White Caps
- Viewing Time Since Last Long-Acting Dose on the Black Cap
- Viewing Long-Acting Dose Amount on the Black Cap
- Viewing Time Since Last Rapid-Acting Dose on the White Cap
- Using your White Cap to View Current Glucose
- Viewing Correction Dose Amount on the White Cap
- Viewing Meal Dose Amounts on the White Cap
- Viewing Meal + Correction Dose Amounts on the White Cap
- 6.3 Using your Caps when Replacing Insulin Pens
- 6.4 Making Diabetes Treatment Decisions
- 6.5 Charging your Caps
- 7 Using the Sensor
- 8 Daily Use and Additional Features
- 9 Care, Maintenance and Disposal of Bigfoot Unity
- 10 Troubleshooting
- Appendix A: Receiving and Responding to Notifications/Alerts on your App/phone
- Appendix B: Settings for Bigfoot Unity App
- Appendix C: Technical Information
- C.1 Labeling Symbols
- C.2 Sensor Specifications
- C.3 Cap Specifications
- C.4 Communications Specifications
- C.5 Bigfoot Unity™ Diabetes Management System Specifications
- C.6 Kit Specifications
- C.7 Security Measures
- C.8 Quality of Service (QoS)
- C.9 Meter Specifications
- C.10 Performance Characteristics of the FreeStyle Libre 2 Flash Glucose Monitoring System*
- C.11 Electromagnetic compatibility (EMC)
- C.12 Warranty
- Index
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The Bigfoot Unity
™
Diabetes Management System User Guide | Appendix C
C.9 Meter Specifications
See the instructions that came with your Meter and the inserts that
came with your test strips and control solution for specications for
those devices.
C.7 Security Measures
The communication between the White Cap and Sensor during a
scan is a short range Near Field Communication (NFC) method which
makes it difcult to interfere with or intercept during transmission.
The transmitted data is protected by a proprietary data format,
encryption, and memory map. The integrity of transmitted data is
ensured by a cyclic redundancy check (CRC) generated by the Sensor
and veried by the White Cap. The communication between the App
and Sensor for Alert data is a standard Bluetooth
®
Low Energy (BLE)
connection. The pairing of the Sensor to the App is accomplished
during activation with an authenticated login procedure that uses an
Out-of-band key exchange (NFC). This prevents unauthorized devices
from connecting to the Sensor. The transmitted data is protected by
a proprietary data format and encryption. This prevents unauthorized
devices from accessing the data if they are within range and intercept
the transmission. Under normal operation, the industry standard BLE
protocols allow for many users to be in the same vicinity. In the case
where the connection is lost due to out-of-range or interference,
reconnection is only possible with the authenticated App that activated
the Sensor.
C.8 Quality of Service (QoS)
QoS for the White Cap and Sensor wireless communications using
NFC is assured within the effective range of 1.0 cm between the
Sensor and Cap that is specied to occur within 15 seconds. QoS for
the wireless communication using BLE is assured between the App
and Sensor at regular 1-minute intervals. If connection is lost between
the App and Sensor for ve minutes, “Sensor Unavailable - Glucose
alerts temporarily unavailable” displays on the App Home screen. If
connection is lost for 20 minutes, the App also alerts the user if the alert
is turned on. If connection is lost between the Sensor and the App, up
to 8 hours of glucose results can be retrieved by performing a scan with
the White Cap. The App and Cap are designed to only accept radio
frequency (RF) communications from recognized and paired Sensors.