User Guide for patients CAUTION--Investigational device. Limited by Federal (or United States) law to investigational use. IMPORTANT USER INFORMATION Review the product instructions before using the Bios device. Instructions can be found in this user manual. Failure to use the Bios device and its components according to the instructions for use and all indications, contraindications, warnings, precautions, and cautions may result in injury associated with misuse of device. Manufacturer information GraphWear Technologies Inc. 953 Indiana Street, San Francisco CA 94107 Website: www.graphwear.co Email:
[email protected] 1 Table of Contents Safety Statement 4 Indications for use 4 Contraindication 5 No MRI/CT/Diathermy - MR Unsafe 5 Warnings 5 Read user manual 5 Don’t ignore high/low symptoms 5 Don’t use if… 5 Avoid contact with broken skin 5 Inspect 6 Use as directed 6 Check settings 6 Where to wear 6 Precaution 7 Avoid sunscreen and insect repellant 7 Keep transmitter close to display 7 Is It On? 7 Keep dry 8 Application needs to always remain open 8 Device description 8 Purpose of device 8 What’s in the box 8 Operating information 11 Minimum smart device specifications 11 Android 11 iOS 12 Installing the app 12 Setting up Bios devices 32 Setting up Left Wrist (LW) device 32 Setting up Right Wrist (RW) device 42 Setting up Lower Abdomen (LA) device 52 2 Confirming that all devices are connected 64 Removing the devices 65 Removing the sensors 67 How to charge the transmitter 69 Setting up and using your Self Monitoring Blood Glucose (SMBG) meter 78 Inserting blood values into the application 79 Inserting meal and exercise information 85 Inserting medication information 89 Change sensor 92 Providing feedback 98 Troubleshooting information 101 What messages on your transmitter display mean 101 FAQ? 102 I need to access the FAQ from my app 102 I am unable to install the mobile application on my smart device.