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.

BodyGuardian One – Instructions for Use 3
ALERT
ON/OFF
Press the ALERT ON/OFF icon to toggle on and off the visual and
auditory alerts that result from leads being disconnected for longer than 10
seconds.
MONITORING
Press the MONITORING icon to return to the Insert ECG lead cable screen
with the
selections enabled.
LANGUAGE
Press the LANGUAGE icon to open a screen where you can select the
language to use in operator mode. You can select English or Spanish. The
selection enables a green check mark. Press the MONITORING icon to
operate the device in the language you selected.
Getting started
1 Prepare your skin
1. If hair is present, remove the hair where you will place the ECG electrodes.
2. Thoroughly clean the area with soap and water. Dry the area completely.
3. Do not apply lotions, oils or perfumes.

BodyGuardian One – Instructions for Use 4
2 Attach electrodes to lead wires
Complete the following steps to attach the electrodes:
1. Snap one ECG electrode into each of the five colored leads.
3 Attach to your chest
1. Remove the adhesive backing from each of the electrodes, then attach them to your
chest:
2. Attach the LA - BLACK lead.
Remove the adhesive backing from the
electrode.
Attach aligned with the left side of the neck,
two to three inches below the left
collarbone.
3. Attach the LL - RED lead.
Apply electrodes only to intact, clean skin. Do not apply over open wounds, lesions,
infected, or inflamed areas. If you have skin allergies or hypersensitivities to
adhesives, consult your doctor to select the appropriate option.

BodyGuardian One – Instructions for Use 5
Remove the adhesive backing from the
electrode.
Attach below the black lead, under the
breast to the outer ribcage.
4. Attach the RA - WHITE lead.
Remove the adhesive backing from the
electrode.
Attach aligned with the right side of the
neck, two to three inches below the right
collarbone.
5. Attach the RL - GREEN lead.
Remove the adhesive backing from the
electrode.
Attach below the white lead, under the
breast to the outer ribcage.
6. Attach the V1 - BROWN lead.

BodyGuardian One – Instructions for Use 6
Remove the adhesive backing from the
electrode.
Attach to the center of the chest, slightly to
the right of the sternum.
4 Route lead wires under and around clothing
Run the lead wires from the electrodes neatly under your clothing to your belt area, where
you will clip the monitor.
5 Power on the monitor
1. Slide the battery cover off the back of the monitor.
All five leads must remain securely attached to the chest during the prescribed
monitoring period. If any one of the leads becomes detached from an electrode worn
on the chest, the device will notify the wearer by displaying the message: CHECK
ELECTRODES.

BodyGuardian One – Instructions for Use 7
2. Insert one of the batteries at an angle so that the battery contacts enter the
compartment first.
3. Drop the cover (as pictured) back onto the monitor, then slide it into place.
4. After the battery is installed, wait 2-3 minutes for the Insert ECG Lead Cable screen. If
that screen does not appear, do not insert the cable; call Preventice for assistance.

BodyGuardian One – Instructions for Use 8
6 Plug lead set into monitor
1. Plug the connector on the lead set cable into the monitor.
The monitor will alert you with a beep when the lead set is securely plugged into the monitor.
2. On the touchscreen, a spinning circle displays. Do not touch the screen.
3. After several seconds, the MONITORING message appears on the screen. You are now
monitoring.

BodyGuardian One – Instructions for Use 9
4. If you see the following screen, press the red RECORD button on the monitor. This will
display the MONITORING screen. You are now monitoring.
7 Take an initial ECG recording
At least 1 minute after the MONITORING screen displays, you must take an initial ECG
recording. This will start your monitoring service.
1. Wait at least 1 minute after you first see the MONITORING screen, then press/hold the
red RECORD button for 3 seconds.
2. On the touchscreen, tap NONE/ACCIDENTAL. Then tap SUBMIT.
3. On the touchscreen, tap RESTING. Then tap SUBMIT.
If the screen changes back to ACTIVATION PENDING after starting
monitoring, contact Preventice at 888.500.3522 (press 1, 1, 4).

BodyGuardian One – Instructions for Use 10
Daily usage
1 Recording your symptoms
If you feel symptoms related to why the monitor was prescribed, such as dizziness, chest pain
or shortness of breath, you can manually record these events. The BodyGuardian One will also
be automatically recording and transmitting asymptomatic cardiac events as they occur
without requiring you to press the Record button or interface with the monitor.
1. Do one of the following to record an event:
•Press the Record button.
•Press the MONITORING bar on the touchscreen.
The BodyGuardian One displays the Select Symptom(s) screen and prompts you to select
the symptoms you are feeling.
2. Use the touchscreen to highlight the symptoms and press SUBMIT. Multiple symptoms
can be selected. The Select Activity Level screen will appear after you submit your
symptom.

BodyGuardian One – Instructions for Use 11
3. Use the touchscreen to highlight the activity (for example, Exercising), and press
SUBMIT.
4. Repeat steps 1 - 3 to record additional events.
2 Charging the BodyGuardian One
The BodyGuardian One is powered by an externally rechargeable lithium-ion battery. Each
device is supplied with two batteries and one battery charger. We recommend charging one
battery while the other is being used in the monitor. Several factors, including the cellular
network coverage quality and the amount of data being transmitted can impact battery life.
Replace the rechargeable battery in the monitor every 24 hours or when the low battery
indicator alerts you. The monitor will alert you with a beep and visual indicator when the
battery is low.
Use only IEC 62133 certified lithium-ion batteries supplied by Preventice with the
BodyGuardian One. It takes approximately 4 hours to charge the BodyGuardian One battery.
Always unplug the lead set cable from the BodyGuardian One monitor prior to exchanging
the battery to prevent any potential loss of data.

BodyGuardian One – Instructions for Use 12
To charge the BodyGuardian One monitor battery:
1. Place the rechargeable lithium-ion battery face down into the charger.
2. Plug the charger into the wall outlet (110 or 220V).
3. Once the battery is properly inserted, the charger displays either a solid blue light
indicating the attached battery is fully charged (or no battery is attached to the
charger), a solid pink light indicating it is charging, or a solid red light if there was an
error in charging the battery, as shown in the following graphics:
Charged Battery
Charging
Charge Error
3 Replacing the electrodes
We recommend changing the electrodes every three days or when they no longer adhere to
your skin.
Notes:
•It is recommended to replace all electrodes at once
•Replace each electrode one at a time
•Never reuse electrodes

BodyGuardian One – Instructions for Use 13
1. Unplug the ECG lead set cable connection from the BodyGuardian One to disconnect
the lead wires and pause monitoring.
2. Unsnap the lead from the old electrode, and then snap the lead to a new electrode.
3. Remove the adhesive backing from the new electrode.
4. Attach the new electrode an inch away from the old electrode. Make sure the
electrodes are attached within the following placement zone:
5. Peel the old electrodes off the skin. Use soap and water to reduce irritation and to
remove any residue. Dispose of the electrodes.
6. Plug the ECG lead set cable into the monitor to resume monitoring.
Note:
Always unplug the cable before changing out electrodes to prevent ECG data loss
All five leads must remain securely attached to chest during the prescribed
monitoring period; this ensures that the device will trigger events properly.

BodyGuardian One – Instructions for Use 14
4 Showering, bathing, swimming
BodyGuardian One is NOT waterproof. Keep the monitor away from water. Remove the
monitor and the lead set wires when you bathe, swim or perform other similar activities, then
re-attach lead wires afterwards. You do not need to remove the ECG electrodes.
5 MRI
BodyGuardian One cannot be worn while undergoing an MRI. Remove the monitor, lead wires,
and ECG electrodes when preparing for an MRI.
6 Air travel
The monitor cannot be worn while traveling on an aircraft. This monitor does not operate
outside the United States. Contact Patient Services if you plan to travel outside the United
States.
7 Touchscreen dimming
Even when the BodyGuardian One is collecting data, the monitor turns off the touchscreen to
conserve battery. This is normal. The monitor is still performing its monitoring functions. It has
simply turned off the touchscreen display. To activate the touchscreen, briefly press and
release the Record button on the monitor.
Maintenance and Service
1 Cleaning
To clean BodyGuardian One monitor:
1. Remove the battery from the monitor. DO NOT TRY TO CLEAN BATTERY.
2. Dampen a soft cloth with a mild detergent and water mixture. An example of a mild
detergent is an alcohol-free hand soap or sodium hypochlorite (bleach) solution 10% in
water.
3. Clean the monitor and ECG lead cables
4. Remove any remaining adhesives from the ECG lead cables with an adhesive tape
remover solution or swab of mild detergent. Avoid kinking the ECG lead cables. Store
cables suspended if possible.
If leads are detached for 10 seconds, the monitor will send an audible and
vibration alert. Notification will repeat every 2 minutes until leads are
reattached.

BodyGuardian One – Instructions for Use 15
2 Service
If there is a problem with BodyGuardian One monitor or accessories, first review
Troubleshooting section for a solution. If you need further help, include monitor’s serial
number and a problem description in an email message to Preventice Customer Support at:
888.500.3522 (press 1, 1, 4).
3 Troubleshooting
Symptom
Solution
No power
Check battery power and recharge.
Install new or fully charged battery.
Low battery
Recharge battery.
Install new or fully charged battery.
Battery charge does NOT last the number of
hours expected
Ensure a new battery is used.
Noise artifacts on ECG signal
Ensure all electrodes are securely attached
and that electrodes used are of quality
recommended.
Ensure ECG lead cable is inserted completely
into monitor.
4 Battery storage
First remove lithium-Ion (li-Ion) battery from BodyGuardian One monitor and then store
monitor and battery at room temperature in a dry area.
If a battery is damaged or no longer holds its charge, recycle it.
Cover the battery terminals (+ and -) with an insulation tape or place the batteries that you
want to recycle into a box or bag, take them to a collection point.
Do NOT immerse monitor in water or any other cleaning solution. Do NOT use
alcohol or acetone to clean ECG lead cables. Alcohol or acetone can cause
cables to stiffen and cables insulating plastic to crack.

BodyGuardian One – Instructions for Use 16
Indications for Use
BodyGuardian One is intended for use by patients who either have or are at risk of having
cardiac disease and those that demonstrate intermittent symptoms indicative of cardiac
disease and require cardiac monitoring on a continuing basis.
Contraindications
BodyGuardian One is NOT intended for use under the following conditions:
•Patients with potentially life-threatening arrhythmias who require inpatient monitoring.
•Patients who the attending physician believes should be hospitalized.
•Infants weighing less than 22 lbs (10 kg).
Precautions
•Use only ECG lead cables provided by Preventice with BodyGuardian One.
•Disconnect ECG lead cable before using a defibrillator.
•When viewing ECG data, the presence of pacemaker signals in the ECG trace should
NOT be considered true representations of the actual pacemaker stimulus amplitude.
Caution: No computerized information is completely reliable, and physicians should
review all ECG results.
•To avoid unintended battery discharge, remove battery from BodyGuardian One when
it will NOT be used for an extended period of time. See Appendix E: Handling
Instructions for Lithium-Ion Battery.
•To receive the best recording results, stay away from heavy electrical equipment or
other sources of electromagnetic interference. Equipment such as electric blankets and
heating pads are included in this group.
•Do NOT expose BodyGuardian One or battery to water or excessive moisture.
•Do NOT expose BodyGuardian One or battery to extreme temperatures beyond the
limits shown in Appendix B: Technical Specifications.

BodyGuardian One – Instructions for Use 17
Appendix A: Symbols
Symbol
Description
Consult Instructions For Use.
Manufacturer
RxOnly
Prescription Only
Type CF Applied Part
Serial Number
Catalog Number
IPX0
Non-protected against fluid ingress