Preventice Technologies BodyGuardian One User manual

Instructions for Use

CONFIDENTIAL AND PROPRIETARY
The information contained in this document is confidential and proprietary to Preventice Technologies, Inc. This
document may not be disclosed, copied, or distributed in any form to any third party without written permission of
Preventice Technologies, Inc.
Copyright © Preventice Technologies, Inc.
February 2021
All rights reserved.
LA1054-A LL-60090-A

BodyGuardian One – Instructions for Use
Table of Contents
Equipment ............................................................................................................................................................................... 1
About BodyGuardian One.................................................................................................................................................. 1
BodyGuardian One menu options .................................................................................................................................. 2
Getting started...................................................................................................................................................................... 3
1Prepare your skin ................................................................................................................................................................ 3
2Attach electrodes to lead wires.....................................................................................................................................4
3Attach to your chest ..........................................................................................................................................................4
4Route lead wires under and around clothing........................................................................................................... 6
5Power on the monitor........................................................................................................................................................ 6
6Plug lead set into monitor ............................................................................................................................................... 8
7Take an initial ECG recording......................................................................................................................................... 9
Daily usage........................................................................................................................................................................... 10
1Recording your symptoms ............................................................................................................................................ 10
2Charging the BodyGuardian One..................................................................................................................................11
3Replacing the electrodes ................................................................................................................................................12
4Showering, bathing, swimming.................................................................................................................................... 14
5MRI .......................................................................................................................................................................................... 14
6Air travel ............................................................................................................................................................................... 14
7Touchscreen dimming..................................................................................................................................................... 14
Maintenance and Service................................................................................................................................................. 14
1Cleaning ................................................................................................................................................................................ 14
2Service....................................................................................................................................................................................15
3Troubleshooting .................................................................................................................................................................15
4Battery storage ...................................................................................................................................................................15
Indications for Use..............................................................................................................................................................16
Contraindications................................................................................................................................................................16
Precautions ...........................................................................................................................................................................16
Appendix A: Symbols ........................................................................................................................................................17
Appendix B: Technical Specifications ..........................................................................................................................18
Appendix C: Wireless Compliance ................................................................................................................................19
Appendix D: Arrhythmia Detection Performance ....................................................................................................21
Appendix E: Handling Instructions for Lithium-Ion Battery.................................................................................22

BodyGuardian One – Instructions for Use 1
Equipment
monitor
monitor (back)
monitor batteries (2)
battery charger
ECG lead wires
standard ECG
electrodes
About BodyGuardian One
The BodyGuardian One is a portable, battery powered, wireless cardiac monitor which may be
worn to record ECG data for up to 30 consecutive days.
The BodyGuardian One captures patient activated and auto-triggered cardiac events, such as
Bradycardia, Tachycardia, and Atrial Fibrillation, that are identified by an embedded
arrhythmia detection algorithm. The device is capable of automatically delivering data to
Preventice.
Important
•BodyGuardian One does not summon physicians nor emergency assistance and does
not replace direct communication with your health care provider. If you are
experiencing a medical emergency, dial emergency assistance (911 US)
•If you have questions or encounter problems while you are using BodyGuardian One,
contact your health care provider.
•For a complete list of indications, contraindications, and precautions, see page 16.

BodyGuardian One – Instructions for Use 2
BodyGuardian One menu options
BodyGuardian One provides additional menu options that can assist you while you are
operating the device.
To access the menu options:
1. Unplug the ECG cable from the device to pause monitoring. The Insert ECG lead cable
screen is displayed.
2. Using the touchscreen, press on the MENU icon.
3. Press the menu option that you want to enable or view.
Label
Description
INFO
Press the INFO icon to display the following:
•Device serial number
•Software version number
•SIM card ID
•IMEI ID
•Firmware version number
FLIGHT MODE
Press the FLIGHT MODE icon to disable network connectivity and prevent
the device from sending data to or receiving data from the Preventice
servers. The device will still be recording ECG/heart rate data.
The icon is highlighted when the option is enabled. Press the icon again to
disable the option.
SOUND
ON/OFF
Press the SOUND ON/OFF icon to toggle on and off the sound from the
device (this includes audible chime alerts).
Note: Unplugging the ECG cable pauses monitoring.