Boston Scientific Preventice Solutions BodyGuardian ONE User manual

Patient Instruction Manual

2
CONTACT INFORMATION Return your monitor on: ------------ / ------------ / ------------
General information
https://www.preventicesolutions.com/patients/body-guardian-one
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.
If you are receiving the monitor at home and require assistance, call Preventice Services at: 888.500.3522
Did you receive your monitor at home?
Patient benefit quotes
888.747.4760
8:00 a.m. - 4:00 p.m. CST, M-F
patientbenefi[e-mail]
Patient services
888.500.3522 (press 1, 1)
24 hours a day, 7 days a week
[e-mail]
Returning your monitor
888.500.3522 (press 1, 5)
7:00 a.m. - 7:00 p.m. CST, M-F
[e-mail]
Billing assistance
888.747.4701
8:00 a.m. - 5:00 p.m. CST, M-F
[e-mail]

3
INSURANCE INFORMATION
Our Notice of Privacy Practices is available for your review at: www.preventicesolutions.com
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.

4
INTRODUCTION
Your physician has prescribed you the BodyGuardian One heart monitor 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.
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/BGO-IFU.pdf
Welcome to
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
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.
BodyGuardian One is NOT waterproof. Keep the monitor away from water. Remove the monitor and the lead
set 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
INTRODUCTION
Ensure that the following equipment is included in the box.
Equipment
Monitor batteries
Monitor
ECG lead set
Batteries (2)Monitor case / belt clip
Battery
charger
ECG lead wires
BodyGuardian One monitor
standard ECG electrodes
Note: Your equipment may vary from the components pictured. Preventice reserves the right to modify, change, or discontinue products or accessories at any time.
touchscreen
record button

6
GETTING STARTED
Prepare your skin
1. If hair is present, remove the hair where you
will place the ECG electrodes.
See page 7 for chest locations.
2. Thoroughly clean the area with soap and
water. Dry the area completely.
3. Do not apply lotions, oils, or perfumes.
Attach electrodes to lead wires
1. Snap one ECG electrode into each of the five
colored leads.

7
GETTING STARTED
Attach to your chest
Remove the adhesive backing from each of the
electrodes, then attach them to your chest:
Black
Attach aligned with the left side of the neck, two to
three inches below the left collarbone.
Green
Attach below the white lead, under the breast to
the outer ribcage.
Red
Attach below the black lead, under the breast to
the outer ribcage.
White
Attach aligned with the right side of the neck, two
to three inches below the right collarbone.
Brown
Attach to the center of the chest, slightly to the
right of the sternum.
patient right patient left
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.

8
GETTING STARTED
Run the lead wires from
the electrodes neatly under
your clothing to your belt
area, where you will clip the
monitor.
Route lead wires
around clothing
Insert battery into monitor
Slide the battery cover off
the back of the monitor.
1Insert one of the batteries
at an angle so that the
battery contacts enter the
compartment first.
2

9
GETTING STARTED
Charge the other battery
1. Place the other battery into the charger.
2. Plug the charger into a wall outlet.
While charging, the charger displays either
a pink (charging) or blue (charged) light.
Charging time: 4 hours
Charged (blue)Charging (pink)
Slide the cover
back onto the
monitor. Drop the
cover as pictured,
then slide it into
place.
3
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.
4

10
GETTING STARTED
3
7Plug 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.
1
2
MONITORING
If the screen changes back to ACTIVATION PENDING after starting monitoring, contact Preventice at
888.500.3522 (press 1, 1, 4).

11
GETTING STARTED
8Take an initial ECG recording
Press the red Record button
on the monitor.
This will display the
MONITORING screen.
You are now monitoring.
If you see this screen ...
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 .
MONITORING
1 2 3
SUBMIT SUBMIT
NONE /
ACCIDENTAL RESTING

12
GETTING STARTED
10 Attach the belt clip to belt
Place monitor into belt clip
Slide the monitor into the belt clip.
9
MONITORING
All five leads must remain securely attached
to your chest during your prescription.

13
DAILY USAGE
Recording your symptoms
If you begin to feel symptoms related to the
reason your monitor was prescribed, such
as dizziness or shortness of breath:
1. On the monitor, press and hold the red
Record button for 3 seconds.
2. Remove the monitor from the belt clip.
3. On the touchscreen, tap the
symptom(s) that you are feeling. You
can select more than one. Then tap
SUBMIT .
4. On the touchscreen, tap your level
of activity when you were feeling the
symptom. Then tap SUBMIT .
5. Slide the monitor back into the belt
clip.
MONITORING
SELECT SYMPTOM(S)
NONE /
ACCIDENTAL
TIRED /
FATIGUED
FLUTTER /
MISSED BEATS
SHORTNESS
OF BREATH
RAPID
HEARTBEAT
CHEST PAIN /
PRESSURE
DIZZINESS PASSED OUT SUBMIT
SELECT ACTIVITY LEVEL
RESTING HEAVY
LIGHT EXERCISING
MODERATE SUBMIT

14
DAILY USAGE
Replace the battery daily
The monitor will alert you with a beep when the battery is low.
1. Remove the monitor from the belt clip.
2. Unplug the lead set connector from the monitor.
Important This step is required before continuing.
3. Slide the battery cover off the back of the monitor. Remove the battery
from the monitor.
4. Insert the fully-charged battery into the monitor at an angle so that the
battery contacts enter the compartment first. The monitor powers on.
5. Slide the battery cover back onto the monitor.
6. Plug the lead set back into the monitor, then slide the monitor into the belt clip.
7. Place the removed battery into the charger. Ensure the charger is plugged
into a wall outlet. See page 9 for details.
Charging time: 4 hours
Replace the rechargeable battery in the monitor every 24 hours or when the low battery indicator alerts you.

15
DAILY USAGE
Replacing the ECG electrodes
1. Remove the leads from the electrodes on your chest.
2. Slowly peel back and roll the adhesive on the back of the electrodes away
from your chest.
For easiest removal, remove electrodes by applying warm water
while showering or blot with a damp cloth.
3. Dispose of the old electrodes.
4. Attach new electrodes to the lead wires.
5. Remove the adhesive backing from each of the electrodes, then attach
them to the your chest. Place new electrodes about one inch away from
the location where the electrodes you just removed were attached.
Electrodes are disposable.
2
If leads are detached for 10 seconds, the monitor will display CHECK
ELECTRODES and send an alert (see Pg. 17 to turn off sound alerts).
Notification will repeat every 2 minutes until leads are reattached.
Change the ECG electrodes every three days OR when they no longer adhere to the skin.

16
DAILY USAGE
MRI
MRI
BodyGuardian One cannot be worn while undergoing an MRI. Remove the monitor, lead wires, and ECG
electrodes when preparing for an MRI.
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.
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.
Air travel
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, press and release the Record button on the monitor.
Touchscreen dimming

17
DAILY USAGE
Completing your prescription
MONITORING COMPLETE
To mute the sound alerts that occur when the leads are
detached for 10 seconds:
1. In the MENU, tap the SOUND ON icon to toggle off
the audible chime alert.
SOUND OFF
SOUND ON
Sound is
on. Tap to
turn sound
off.
Sound is
off. Tap to
turn sound
on.
2. Save the changes by pressing the Record button .
3. Plug the leadset back into the monitor to resume
MONITORING .
Turn off sound alerts
At the end of your monitoring prescription, the monitor
will display the MONITORING COMPLETE screen.
Once your monitoring prescription is complete, follow
the instructions on the next page for returning your
equipment.
To change monitor settings, unplug the leadset
from the monitor, then tap the MENU button
on the touchscreen.

RETURNING EQUIPMENT
Return your equipment immediately after your service ends
If you are returning your equipment to Preventice Services:
1. Remove the battery from the monitor.
2. Place the monitor into the foam pouch provided, then into the original
postage-paid box. Then place the batteries, battery charger, belt clip, ECG
lead set, any unused ECG electrodes, and patient survey into the box.
3. Remove the adhesive strip from flap on the shipping box and seal
securely. The prepaid return label is already affixed to the bottom of
the box.
4. Drop package off at the shipping carrier listed on the prepaid return label.
For assistance, call Preventice at 888.500.3522.
If you have lost or damaged the equipment, Preventice will mail you an invoice for the cost of the item.
If you are returning your equipment to your health care provider:
1. Follow the instructions provided by your health care provider.

PATIENT SURVEY
We appreciate your feedback. Please return this survey inside the box once your study is completed.
This survey can also be completed online at: https://www.preventicesolutions.com/patients/patient-survey
Rate our service level 1 2 3 4
General satisfaction with Preventice Services
Ability to get through on the phone
Explanations given to hook up your monitor
Amount of time the representative spent with you
Rate the contents of the materials 1 2 3 4
Printed instruction manual included in your box
Excellent Poor Average
Patient name City State
Doctor's office / hospital
My hook-up took place at: Home
Contact me via: Phone
EmailPhysician's office
Not
applicable
continue

PATIENT SURVEY
Comments
I hereby authorize Preventice Solutions, Inc. to use, reuse, publish or republish my name in light of any communication I made and photographic likeness in all forms and all media for
advertising, marketing, and any other lawful purposes. I release and discharge Preventice Solutions, Inc. from any and all claims and demands that may arise out of or in connection with
the use of photographs, name or likeness, including without limitation any and all claims for libel or violation of any right of publicity or privacy. I have read this release and fully understand
its contents, and I reserve the right to revoke this release upon written request to: Preventice Solutions, Inc. 1717 N. Sam Houston Parkway West, Suite 100 Houston, Texas 77038
Rate your experience using the monitor and its accessories 1 2 3 4
Setting up the monitor
Wearing and charging the monitor
Adherence and comfort of the ECG electrodes
Shipment of supplies for the length of your study
Excellent Not
applicablePoor
Average
L-22_PIM-BGO01EN_Rev 7.0 Copyright © 2021 Preventice Solutions – All rights reserved.