BodyGuardian Heart User manual

Preventice Services, LLC and Preventice Technologies, Inc., are independent, wholly owned subsidiaries of Preventice Solutions, Inc.
Patient Instruction Manual

2
CONTACT INFORMATION
Patient services
Phone: [phone] (press 1, 1) Email: [e-mail]
Hours: 24 hours a day, 7 days a week
Returning your monitor
Phone: [phone] (press 1, 5) Email: [e-mail]
Hours: 7:30 a.m. - 7:00 p.m. CST
Billing assistance
Phone: [phone] Email: [e-mail]
Hours: 8:00 a.m. - 5:00 p.m. CST
General information
Web: www.preventicesolutions.com/patients.html
Return your monitor on: ------------ / ------------ / ------------
Preventice Services is not an emergency response service. Contact your doctor immediately if your
symptoms worsen. If you are experiencing a medical emergency, dial 911.
The BodyGuardian Connect smartphone cannot be used to make phone calls, including calls to 911,
or perform other smartphone functions. Viewing the smartphone is prohibited while driving, operating heavy
machinery or in situations that may jeopardize your safety.

3
INSURANCE INFORMATION
On behalf of your physician, you are being provided with a heart monitor from Preventice Services. This test
will be billed in two parts:
1. Your medical professional will bill your insurance for the in-office hook-up and the final reading of the test results.
2. Preventice Services will bill your insurance for the use of the monitor along with providing the physician with
24/7 monitoring center service and all requested data and reports.
Your insurance company will usually send you an Explanation Of Benefits (EOB) describing the amount paid and
the amount you owe Preventice. An EOB is not a bill.
Our goal is to help your physician diagnose your heart condition without delay or concerns about billing. We offer
patient-friendly payment options, including a discounted rate at the time of service or a reduced rate when your
insurance indicates a large fee payable by you for our services or the physician’s services.
All equipment is the sole property of Preventice Services. To avoid financial liability and to ensure that you do
not receive a bill for the value of the equipment in your possession (up to $2,400), please return the equipment
immediately after your service ends. Any request for an extension of your study beyond your prescribed study
needs to come from your physician through a new order sent to Preventice Services. Be aware that the second
study may not be covered by all insurance providers and you may be responsible for those charges.
Our Notice of Privacy Practices is available for your review at www.preventicesolutions.com
Patient financial obligations and billing information

4
INTRODUCTION
Your physician has prescribed you the BodyGuardian Heart Remote Monitoring System and monitoring center
service provided by Preventice Services to detect irregular heart rhythms. You must wear the monitor for the
length of time your doctor has prescribed.
Instructional videos with subtitles and online help are available on BodyGuardian Heart smartphone to help you
use your monitor. From the Home screen, tap Help and Settings → Videos.
For additional resources, visit: www.preventicesolutions.com/patients.html
If you are receiving the monitor at home and require assistance, call Preventice Services at: 888.500.3522
For the manufacturer’s Instructions for Use, visit: www.preventicesolutions.com/docs/BGH-IFU.pdf
Resources and assistance
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.
Welcome to BodyGuardian Heart
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Remove BodyGuardian Heart as soon as your physician or qualified health care professional ends your
service. Any data or information transmitted or received by Preventice after your physician or qualified health care
professional has ended your service will not be processed, reviewed or analyzed by Preventice, and Preventice
shall have no liability for any such information or data.
When your study concludes

5
INTRODUCTION
Ensure that the following equipment is included in the box.
Equipment
BodyGuardian Connect
smartphone
Note Your equipment may vary from the components pictured. Preventice reserves the right to modify, change, or discontinue
products or accessories at any time.
monitor charging
cradle
power cord with
adapter
BodyGuardian Heart monitors (2)
The 1and 2stickers help to distinguish the monitors
from one another. Do not place stickers on the bottom
of the monitor. Your monitors may be white or black.
Both versions operate identically.
smartphone charger
BodyGuardian Base
standard ECG electrodes

6
GETTING STARTED
With one monitor firmly snapped into the charging
cradle, plug the charging cradle into a wall outlet.
All monitor lights will go out when the monitor is fully
charged.
Charge one of the monitors
Plug the charger into the smartphone and a wall
outlet. The smartphone is fully charged when the
battery indicator on the screen is solid green.
Charge the smartphone
Charging the smartphone can take up to 4 hours.
Charging
Fully charged
Charging Fully charged
Prepare your skin
1. If hair is present, remove the hair where you will
place the monitor (see p.9 for chest locations).
2. Thoroughly clean the area with soap and water.
Dry the area completely.
3. Do not apply lotions, oils, or perfumes.

7
GETTING STARTED
1. Line up the snaps on the monitor and the Base.
The snaps aren’t evenly spaced. To make sure
the snaps are lined up, the orientation of the
logo on both the monitor and the Base must be
the same.
2. Snap the monitor to the Base. Press firmly to
securely connect all four snaps one by one.
3. Snap the electrodes to the Base.
4. Firmly snap the second monitor into the
plugged-in charging cradle so it is charged and
ready when you switch monitors.
• The amber battery light on the monitor will
come on while it is charging.
• All monitor lights will go out when the monitor
is fully charged.
Snap the charged monitor to the
Base for the first time
Charging
Fully charged
1
2 3
4

8
GETTING STARTED
continue
1. Peel away the backing, including the flap, from
the electrodes.
2. Place on your chest in one of the locations
shown at right. Make sure one of the two arrows
on the Base is pointing up.
3. Ensure the Base is spread out
evenly.
Attach BodyGuardian Heart to
your chest
Apply 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. If you experience adhesive irritation, apply on
unaffected skin or contact Preventice for alternative
options.
To request additional or alternative supplies:
Phone: [phone] (press 1, 1, 3)
Email: [email protected]
Warning
Note Wear one of the two monitors at a time. One monitor
should be in the charging cradle while you wear the
other on your chest.

9
GETTING STARTED
Examples of incorrect placement
Preferred chest placement
Placement
Horizontally, or nearly horizontally, on the upper chest
Two fingers below the clavicle
Placement can be angled to avoid muscle and fatty
tissue and to achieve tight adhesion to skin
75°70° 80° 85°
Alternate chest placement
Placement
Vertically, or nearly vertically, on the sternum
 Offset slighty to your left side, closer to the heart
Placement can be angled clockwise from vertical if the
straight vertical position is difficult:
10°5° 15°0°

10
GETTING STARTED
Turn on monitor
1. Press and release the center button on the
monitor. Do not hold the button down. The green
center light on the monitor will remain lit or
blinking once it has powered on.
2. Once the monitor is powered on, it will
automatically connect to the smartphone.
3. Stay within 3 feet of the phone, remain still, and
watch the phone for Strip contact errors. If you
receive a Poor Contact message, see p.16.
Congratulations
Once you see the Monitoring Status on the
smartphone change to Monitoring, you have
successfully set up your monitor.
Turn on smartphone
1. Press and hold the power key.
2. Wait 60 seconds for the phone to establish a
network connection.

11
DAILY USAGE
Keep the smartphone within 10
feet of the monitor at all times
Charge the smartphone nightly
Fully charged
Keep the smartphone with you. However, if (1) you get
separated from the smartphone, (2) the smartphone battery
depletes or (3) you go out of cellular network range, the
monitor will continue to collect data and automatically send
it when the smartphone is back in range.
Ensure the smartphone is within 10 feet of the location
where you sleep. Leave the smartphone turned on and plug
it into the smartphone charger and into a wall power outlet.
The smartphone is fully charged when the battery indicator
on the screen is completely solid green.
Note: If you don’t want to be disturbed by alerts while
sleeping or while at an event, tap Do Not Disturb on
the smartphone.
DAILY USAGE
Tip The smartphone supports multiple languages. Tap Help and Settings → Settings → Change Language.

12
DAILY USAGE
Tip: You can switch monitors without removing the
Base and electrodes from your chest.
Wear one of the monitors on your chest while the other remains in the charging cradle. Switch the monitor on your chest:
 First thing in the morning
At night before you go to sleep
At any time if the battery is low
Charging
Fully charged
1
2
To remove the monitor on your chest from the Base:
1. Hold the Base and electrode against your skin,
then unsnap the monitor from the Base.
To make it easier to reattach the fully-charged
monitor, leave the Base snapped to the electrodes
on your chest
2. Snap the monitor into the plugged-in charging
cradle.
Do not power off the monitor. It will
automatically power off when it is done
transferring data.
Switching monitors
Removing the monitor from the Base
continue

13
DAILY USAGE
To attach the fully-charged monitor to the Base:
1. Slip a finger or thumb behind the Base on your
chest, between the electrodes.
2. With your finger or thumb behind the Base, align
and snap the monitor to the Base one snap at a
time.
3. Power on the monitor by pressing and releasing the
center button.
Do not hold the button down. The phone will
automatically detect the new monitor.
4. Stay within 3 feet of the smartphone, remain still,
and watch the smartphone for contact errors. If
you receive a Poor Contact message, see p.16 of
this manual.
Attaching the charged monitor to the
Base
1 2
3 4
Switching monitors (continued)

14
DAILY USAGE
Recording your symptoms
If you begin to feel symptoms related to the reason your
monitor was prescribed such as dizziness, chest pain
or shortness of breath, you can manually record these
events.
1. Press and release the center button on the monitor.
2. Hold as still as possible for 60 seconds.
3. On the smartphone, select the symptoms you are
feeling. You may select up to 3 symptoms.
4. Tap Save.
You must scroll to
see the full list of
symptoms.

15
DAILY USAGE
Replacing the electrodes
Change the electrodes when they no longer adhere to the skin. Electrodes are disposable.
Do not rip or tear off the electrodes quickly. Improper removal may cause skin irritation.
1. Remove the monitor and Base from your chest.
2. Slowly peel back and roll the adhesive on the back of the electrode away from your chest.
Tip: Dampen with water to ease removal from your skin or remove while in the shower.
When do I need to remove BodyGuardian Heart from my chest?
Showering, bathing, swimming Airline travel, MRI
Remove: monitor
The monitor is NOT waterproof.
Remove: monitor, Base,
electrodes
1. On the smartphone, tap Pause. Then tap Yes.
2. Remove Base from electrodes on chest.
3. When you are ready to reattach, dry off your skin
and electrodes completely. Then snap the monitor
back onto the Base on your chest.
4. On the smartphone, tap OK to resume monitoring.
Important: Only use the Pause button when you shower, bathe, swim, travel on an airplane, or undergo an MRI.
1. On the smartphone, tap Pause. Then tap Yes.
2. Remove Base, monitor, electrodes from chest.
3. When you are ready to reattach BodyGuardian
Heart, snap new electrodes to the Base and place
on your chest.
4. On the smartphone, tap OK to resume monitoring.
Pausing and removing Pausing and removing

16
TROUBLESHOOTING
CAUSE
This message indicates poor contact between your skin, the monitor and electrodes.
It is NOT related to the Bluetooth or cellular connection of the smartphone.
Check the monitor snaps
Ensure all snaps are securely fastened between the monitor and the Base.
Check the chest application
Skin preparation
Ensure that the skin on the placement location on your chest has been
prepared appropriately:
• Remove hair, excess oils, lotions, perfumes, etc. The placement
location should be clean and dry.
• Wash the placement location with soap and water. Use alcohol if
soap and water are not available.
Tap OK
Tap OK on the smartphone to dismiss the message.
RESOLUTIONS
Poor Contact message appears on the
smartphone
a.
continue

17
TROUBLESHOOTING
Chest placement location
Ensure that BodyGuardian Heart is positioned properly on the chest.
See p.9 of this manual for chest placement locations.
Ensure one of two arrows on the Base is pointing up.
Tip For the horizontal position, some patients acquire a better signal
when BodyGuardian Heart is placed higher up on the chest, closer
to the collarbone, to avoid fleshy tissue areas. BodyGuardian Heart
receives a higher quality signal when placed over firmer areas.
Electrode-to-skin adhesion
Ensure that the electrodes are securely adhered to the skin without
wrinkles or bubbles. When applying the electrodes, apply pressure to
ensure good contact with the skin.
Replace the electrodes
1. Ensure that the chest placement location is properly prepared. See 3a. Skin preparation.
2. Snap new electrodes to the Base, remove the backing on the electrodes, then place on your chest.
If the message persists, contact Preventice: 888.500.3522 (press 1, 1, 4).
b.
c.

18
TROUBLESHOOTING
If no monitor lights are lit, the monitor is not
powered on. To power on the monitor:
1. Press and release the center button on the monitor.
Do not hold the button down.
2. Once the monitor powers on and the smartphone
connects to the monitor, Monitoring Status will
change to Monitoring.
Note: If there is data on the monitor, the smartphone
will download that data before it moves to a status of
Monitoring. This could take several minutes.
The Pause button on the smartphone
is disabled OR Monitoring Status on
the smartphone is 'Searching'
CAUSE
These conditions occur when the smartphone is not
connected to one of your monitors. This problem is often
caused when neither monitor is powered on. This occurs
most often when switching monitors.
Check to see if the monitor is powered on.
RESOLUTION

continue
1 2

19
TROUBLESHOOTING
If any monitor lights are lit, the monitor is powered on.
If the monitor is powered on, check to see if the smartphone is downloading
data.
1. On the smartphone, tap Monitoring Status.
2. Tap the blue arrows to display both monitors.
3. If the smartphone displays a monitoring status of Downloading
data that means data is being downloaded from the monitor to the
smartphone. Tap the white Downloading data entry. This will display
orange radiating rings that indicate that downloading is active.
Note: If the smartphone does NOT display Downloading data,
contact Preventice: 888.500.3522 (press 1, 1, 4).
4. Once the smartphone has finished downloading, the status on the
smartphone will change to Monitoring. This could take several minutes.
Note: The smartphone must be within 3 feet of the monitor on your
chest to efficiently complete the downloading process.

2. Tap blue arrows
1. Tap Monitoring Status
3. Phone will connect
If the issue persists, contact Preventice:
888.500.3522 (press 1, 1, 4).

20
TROUBLESHOOTING
When switching monitors, the smartphone displays
‘Downloading data’ for an extended time
CAUSE
This occurs when there is a large amount of collected data on the monitor that is
currently being downloaded to the smartphone.
RESOLUTION
Wait for the smartphone to finish downloading.
1. Keep the smartphone within 3 feet of the monitor you just placed on your
chest to allow the downloading process to complete.
2. Once the smartphone has finished downloading, the status on the
smartphone will change to Monitoring. This could take several minutes to
several hours depending on the amount of data to be downloaded from the
monitor.