Instructions for Use
This IFU document is available in other languages upon request.
0086
AT AU BE CH DA DE FR
GB IE IT LT LU NL PL
Hereby, Preventice® declares that this remote monitoring device is
in compliance with the essential requirements and other relevant
provisions of Directive 1999/5/EC. The declaration of conformity is
available at:
3033 41st St NW
Rochester, MN 55901
USA
i
CONFIDENTIAL AND PROPRIETARY
The information contained in this document is condential 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.
BodyGuardian® Heart Remote Monitoring System is a registered
trademark of Preventice Technologies, Inc.
Copyright © Preventice Technologies, Inc.
November 2017
All rights reserved.
LA1001-D
LL-60003-N
Health care provider
QUESTIONS AND CONCERNS
Proper use of this device requires training provided by
your health care provider.
If you have questions or encounter problems while you
are using the BodyGuardian® Heart Remote Monitoring
System, contact your health care provider.
Phone number
Use this space to write down the name and
phone number of your health care provider.
BodyGuardian Heart Instructions for Use
ii
Contents
BodyGuardian Heart kit iv
About BodyGuardian Heart 1
How BodyGuardian Heart works 3
Getting started 4
Before you begin 4
Begin using BodyGuardian Heart 5
Using the smartphone 11
Keep the smartphone with you 11
Charge the smartphone nightly 11
If the touch screen dims 12
Smartphone display 12
Recording symptoms 17
Manually 18
Automatically 18
Selecting your symptoms 19
Switching monitors with Strips 20
Removing a monitor from the Strip 20
Attaching a charged monitor to the Strip 20
Replacing the Strip 21
Switching monitors with a Base 22
Removing a monitor from the Base 22
Attaching a charged monitor to the Base 23
Replacing the electrodes 23
Daily usage 24
Showering, bathing, or swimming 24
Traveling on aircraft 24
Undergoing an MRI 25
Cleaning the monitor 25
Storing the monitor and charging cradle 25
iii
Contents
Figures
Figure 1. BodyGuardian Connect smartphone 2
Figure 2. BodyGuardian Heart Remote Monitoring System 3
Figure 3. Monitor on Strip 6
Figure 4. Monitor alignment on Base 6
Figure 5. Monitor on Base with electrodes 7
Figure 6. Monitor orientation on chest 8
Figure 7. Smartphone – home screen 12
Figure 8. BodyGuardian Connect – status screen 14
Figure 9. Monitoring status 16
Figure 10. Selecting symptoms 19
BodyGuardian Heart monitor lights 26
Indications for Use
Intended Use 27
Warnings / Precautions 28
Appendix A: Specications & symbols 29
Appendix B:
Electromagnetic environment 31
Index 33
BodyGuardian Heart Instructions for Use
iv
BodyGuardian
Connect smartphone
monitor charging cradle /
power cord with adapter
BodyGuardian Heart kit
smartphone charger
BodyGuardian Heart
monitors (2)
Note: Your monitors may
be white or black.
Both versions operate
identically.
standard ECG electrodes
Base
Your health care provider will supply you with either:
Strips
BodyGuardian Strips BodyGuardian Base
1
About BodyGuardian Heart
About BodyGuardian Heart
BodyGuardian® Heart Remote Monitoring System is a
wearable, remote cardiac monitoring system prescribed by
your health care provider. Wearing BodyGuardian Heart allows
your doctor to measure your electrocardiography (ECG) data,
as well as other physiological information, such as breathing
rate, heart rate, and activity level.
BodyGuardian Heart includes the following components:
BodyGuardian Heart monitors
2 – monitors
1 – charging cradle
1 – charging cradle power cord with adapter
BodyGuardian Connect smartphone
1 – cellular smartphone
1 – charger
Strips or Base and standard ECG electrodes
(supplied by your health care provider)
BodyGuardian Heart does not summon physicians
or emergency assistance (911 US, 112 EU, 000 AU)
and does not replace direct communication with your
health care providers.
Warning
Use only the approved power cords supplied with the
system when charging the monitors and smartphone.
All BodyGuardian Heart components must comply with
relevant IEC or ISO safety standards.
1
BodyGuardian Heart Instructions for Use
2
BodyGuardian Connect smartphone reference
BodyGuardian Connect is congured to work as a
component of BodyGuardian Heart. It cannot be used to
make phone calls, including calls to 911 (US), 112 (EU),
000 (AU), or perform other smartphone functions.
Figure 1. BodyGuardian Connect smartphone
Phone battery
Cellular signal strength
Power / Lock key
Touch screen
Volume key
Phone keys (disabled)
Note:
The phone keys are
disabled for use with
BodyGuardian Heart.
Power connector
3
About BodyGuardian Heart
How BodyGuardian Heart works
The complete BodyGuardian Heart Remote Monitoring
System, as shown in Figure 2, consists of components to
monitor and collect your physiological data. That data is sent
over the Internet and stored in secure databases, available to
be accessed and reviewed by your health care professionals.
Patient
Monitor on chest
communicates
with smartphone.
Secure database
Smartphone sends
cardiac data to
secure database
servers.
Doctor
Doctor views
patient data via
secure Internet
connection.
cellular Internet
Figure 2. BodyGuardian Heart Remote Monitoring System
BodyGuardian Heart Instructions for Use
4
Getting started
This chapter will help you set up and start wearing
BodyGuardian Heart for the rst time.
Before you begin
Before you begin wearing BodyGuardian Heart:
• Allow time for BodyGuardian Heart and all accessories to
reach operating temperature (10 to 45 C).
• Charge your devices, and, if necessary, shave the chest
location where you will wear the monitor.
• Use the following instructions to guide you.
Charge the smartphone
Plug the phone charger into the smartphone and a wall outlet.
The phone is fully charged when the battery indicator on the
phone screen is completely green.
charging fully charged
2
5
Getting started
Charge one of the monitors
You must fully charge one of the two monitors before you
begin wearing the device:
1. Plug the monitor charger into the charging cradle and a
power outlet.
2. Snap one of the monitors into the cradle.
Tip: The snaps aren’t evenly spaced. The three monitor
lights should be adjacent to the power cord that is
plugged into the charging cradle.
charging
fully charged
3. Allow the monitor to charge completely. All lights will
go out when it is fully charged.
Charging a monitor just out of the kit can take
approximately 2-3 hours.
Begin using BodyGuardian Heart
You are now ready to begin using BodyGuardian Heart.
Do you have Strips or the Base?
Your health care provider has supplied you with either
BodyGuardian Strips or a BodyGuardian Base (with standard ECG
electrodes). Follow the instructions applicable to your equipment.
?
Strip Base
BodyGuardian Heart Instructions for Use
6
This section is for STRIP patients only
Attach charged monitor to Strip
Be sure you are using a fully-charged monitor.
1. Line up the monitor and Strip, as shown in Figure 3.
Figure 3. Monitor on Strip
Tip: The snaps aren’t evenly spaced. The orientation of
the logo on both the monitor and the Strip must be the
same.
2. Press rmly so all four snaps are connected.
This section is for BASE patients only
Attach charged monitor to Base
Be sure you are using a fully-charged monitor.
1. Line up the monitor and Base, as shown in Figure 4.
Figure 4. Monitor alignment on Base
Tip: The snaps aren’t
evenly spaced. The
orientation of the logo
on both the monitor
and the Base must be
the same.
2. Press rmly so all four snaps are connected.
7
Getting started
3. Snap the electrodes to the Base.
Figure 5. Monitor on Base with electrodes
Prepare your skin
• If hair is present on the chest location identied by your
health care provider, shave the area.
• Clean the area with soap and water or an alcohol wipe.
• Dry your skin completely.
• Do not apply anything to your skin, such as lotions, oils,
sprays.
Do not apply BodyGuardian Heart over open wounds,
lesions, infected or inamed areas. Apply only to
intact, clean skin. If you have known skin allergies or
hypersensitivities to adhesives, consult your doctor.
BodyGuardian Heart Instructions for Use
8
Attach BodyGuardian Heart to your chest
1. Peel away the adhesive backing on the Strip or Base
electrodes.
2. Place the monitor on your chest in one of the placement
options shown at right.
3. Whether you wear the monitor horizontally or vertically,
one of the arrows should be pointing up (Figure 6).
Figure 6. Monitor orientation on chest
Horizontal Vertical
4. For Strip users, apply nger pressure over the gel pads
on the Strip to achieve a tight, smooth connection with
the skin. It may take a minute or so to form a good
connection with the skin and contours of the chest.
Gel pads
9
Getting started
Important Avoid placement over thick muscle and fatty tissue.
Preferred placement options (vertical)
Offset slightly to your left side, closer to your heart.
RightLeft LeftRight
You can angle this placement up to 30° clockwise from
true vertical to avoid muscle, fat, and bra.
OrientationAngle
Do not exceed 30°
clockwise from vertical
30°
0°
Alternate placement options (horizontal)
Two ngers below the collarbone.
You can angle this placement up to 30° clockwise from
true horizonal to avoid muscle, fat, and bra.
OrientationAngle
Right
Right
Left
Left
0°
30°
Do not exceed 30° counterclockwise from horizontal
BodyGuardian Heart Instructions for Use
10
Examples of incorrect placement
Too far to
right side of
chest
Too low, too
far to left
side of chest
Too low Too low
Power on the monitor
1. Press and release the center button on the monitor.
Do not hold the button down.
2. The green center light on the monitor will remain lit or
blinking once it has powered on.
3. Firmly snap the second monitor into the plugged-in
charging cradle to begin charging. The amber battery
light will come on.
Link monitor to the smartphone
1. Press and hold the Power / Lock key
to turn on the smartphone. The
Power / Lock key is located in one of
two locations, depending on the
model of your phone.
2. Once you turn on the smartphone, you will be
prompted to view a series of screens that assist you in
getting the monitor set up and attached to your chest.
3. After you have completed the setup screens and tap
Finish, the smartphone will automatically connect to the
monitor on your chest. This may take up to 2 minutes.
Tip: Stay within 3 feet of the phone, remain still, and
watch the smartphone for contact errors.
11
Using the smartphone
Using the smartphone
The BodyGuardian Connect smartphone is specically
congured to work with BodyGuardian Heart. It cannot
be used make phone calls, including calls to 911 (US),
112 (EU), and 000 (AU), or perform other functions
outside of the BodyGuardian Heart.
Keep the smartphone with you
It is best to keep the phone in the same room with you when
wearing the monitor.
If you are away from the smartphone or the smartphone
battery drains:
The monitor will continue to collect your data and
automatically send it to the smartphone when the
smartphone is available again.
If the smartphone goes out of cellular network range:
The monitor will continue to collect your data. Once the
cellular network is available again, your smartphone will
automatically send your cardiac data to your health care
provider.
Charge the smartphone nightly
Plug your smartphone into the charger near your bed each
night before you go to sleep.
1. If you don’t want to be disturbed by alerts while
sleeping, tap Do Not Disturb on the smartphone.
2. Leave the smartphone on.
3. Plug the smartphone into the plugged-in smartphone
charger in your bedroom.
Continue wearing the monitor while the smartphone charges.
3
BodyGuardian Heart Instructions for Use
12
If the touch screen dims
Even when the smartphone is collecting data, the smartphone
turns off the touch screen when you do not use the phone for
a specied period. If you need to turn on the screen, press the
Power/Lock key on the right edge of the smartphone.
Smartphone display
The smartphone has a dedicated interface to help you monitor
system status, record symptoms, and understand indicator
light symbols.
Smartphone – home screen
The smartphone home screen (Figure 7) is displayed when you
power on or wake your phone.
Figure 7. Smartphone – home screen
13
Using the smartphone
Monitoring Status
Tap to view monitor status and battery level, strength of
skin contact with Strip or Base, as well as current heart rate,
breathing rate, and activity level.
Pause
Tap to temporarily suspend the collection of data from the
monitor. This can be used when you need to remove the
monitor for a short time.
Example uses:
• When showering, bathing, or swimming
• While undergoing an MRI
Do Not Disturb
Tap to turn off sound and vibration alerts associated with
the BodyGuardian Connect status monitors.
Example uses:
• Before you go to bed
• While attending church
My Tasks
Tap to access screens to record weight, blood pressure,
and monitor chest placement.
Help & Settings
Tap to display information to help you use BodyGuardian
Heart. This button does NOT call for medical help.
BodyGuardian Heart Instructions for Use
14
BodyGuardian Connect – status screen
The BodyGuardian Connect status screen (Figure 8) displays:
• Monitor status and battery level
• Strength of skin contact with Strip or Base electrodes
• Current heart rate, breathing rate, and activity level
Back
Status bar
Contact strength
Monitor battery
indicator
Heart Rate
Breathing Rate
Activity Level
Monitor toggle
Figure 8. BodyGuardian Connect – status screen
Note: These are optional
features that may not
be activated for you.
The information on this screen refreshes automatically
every 60 seconds.
15
Using the smartphone
Back
Tap to return to the previous screen.
Status bar
Displays the current status of the displayed monitor.
Monitor toggle
Tap to view your other monitor. Allows you to view the
status of your other monitor while it is in the cradle
downloading, for example.
Contact strength
Displays the strength of the ECG signal. A strong
connection between the Strip or Base electrodes and
your skin is necessary for the monitor to read your ECG
information. To achieve strong contact:
• All four monitor snaps must securely fasten the monitor
to the Strip or Base.
• For Base users, the standard ECG electrodes must be
securely snapped to the Base.
• The Strip or Base electrodes must be securely attached
to chest.
Monitor Battery
Displays the current battery level of the monitor.
Heart Rate
(optional feature, may not be activated)
Displays your heart beats per minute.
Breathing Rate
(optional feature, may not be activated)
Displays your number of breaths per minute.
Activity Level
(optional feature, may not be activated)
Displays a relative characterization of your physical activity
on a scale of 1-100.
BodyGuardian Heart Instructions for Use
16
Monitoring status
The status bar displays the monitor status.
Status bar
Figure 9. Monitoring status
Possible statuses are:
Monitoring
BodyGuardian Heart is monitoring your cardiac information
normally.
Searching
The phone is actively looking for a monitor. It is possible
that both monitors are powered off or the monitor is out of
range.
Connecting
The phone has found a monitor that is powered on and is
establishing contact.
Re-connecting
The phone is re-establishing contact with the monitor.
Checking contact
BodyGuardian Connect is checking to see if contact is
strong enough to begin a monitoring session.
Connected
BodyGuardian Connect has established contact with a
monitor and will begin monitoring momentarily.
Downloading data
The phone is downloading your cardiac data from the
monitor.
Not available
The monitor is not in use. BodyGuardian Heart is actively
monitoring with another monitor.
17
Recording symptoms
Recording symptoms
This chapter describes the symptoms function. This
feature may not be activated for you by your health
care provider.
If you experience any symptoms – such as trouble breathing,
dizziness, or racing heartbeat – while wearing the monitor,
it can be useful for your doctor to be able to identify when
you experienced them. This allows your doctor to assess your
cardiac information during the time you were feeling particular
symptoms.
When symptoms occur, you will be prompted on your
BodyGuardian Connect smartphone to select the symptoms
you were feeling at that time.
There are two types of triggers that will prompt you to select
and record your symptoms:
Manual
You click the center button on the monitor on your chest
when you are feeling symptoms.
Automatic
The monitor automatically detects that you may be
experiencing cardiac symptoms, even something mild.
4
BodyGuardian Heart Instructions for Use
18
Manually
Your doctor may ask you to keep track of certain symptoms,
such as dizziness or racing heartbeat. When you feel any of
these symptoms:
1. Press and release the button in the center of the
monitor.
2. BodyGuardian Heart will record and send your
cardiac information to your care team. This helps
them understand your symptoms and review your
information.
BodyGuardian does not summon physicians or
emergency assistance (911 US, 112 EU, 000 AU) and
does not replace direct communication with your
health care providers.
Automatically
As BodyGuardian Heart monitors your cardiac information,
it detects when you may be experiencing important cardiac
events, even mild ones.
If this occurs, your BodyGuardian Connect smartphone will
automatically prompt you to select the symptoms you are
feeling at that time.
19
Recording symptoms
Selecting your symptoms
When your BodyGuardian Connnect smartphone prompts you,
either manually or automatically, select all of the symptoms
you are feeling at the time (Figure 10).
If you accidentally click the monitor button and are not feeling
any symptoms, select:
No symptoms
Figure 10. Selecting symptoms
Tip
Scroll to see the entire
list of symptoms.
BodyGuardian Heart Instructions for Use
20
Switching monitors with
Strips
Do you have Strips or the Base?
This chapter applies to patients with BodyGuardian Strips.
If you are using the BodyGuardian Base, see Chapter 6.
?
Wear one of the monitors while the other one remains in the
charging cradle. Switch the monitor on your chest:
• In the morning after you wake up
• At night before you go to bed
• During the day if the battery is low
Removing a monitor from the Strip
You can switch monitors without removing the Strip from your
body. You do not need to perform any tasks on the phone
when switching monitors.
1. Use nger pressure to hold the Strip against your skin.
2. Gently lift a corner of the monitor. Continue lifting
gently until all four snaps release.
1 2
3. Snap the used monitor into the plugged-in charging
cradle.
Do not pause or power off the monitor.
The monitor will automatically power off when it is
done transferring data.
Attaching a charged monitor to the Strip
5
21
Switching monitors with Strips
Remain near the phone when switching monitors. You can
attach the fully charged monitor while the other monitor is in
the charging cradle and transferring data before it powers off.
1. Snap the fully-charged monitor to Strip.
2. Power on the monitor by pressing and releasing the
center button. Do not hold the button down.
1 2
3. If prompted by the smartphone, select the location
where you positioned the monitor on your chest.
Replacing the Strip
Change the Strip every three days OR when it no longer
adheres to the skin.
1. Remove the monitor from the Strip.
2. Remove the Strip while showering or use a warm, damp
cloth to soften the edges of the Strip.
3. Slowly peel back and roll the adhesive away from your
chest. Continually blot the chest and adhesive with a
warm, damp cloth.
Do not rip or tear off the Strip quickly.
Improper removal may cause skin irritation.
Note: Strips are disposable.
BodyGuardian Heart Instructions for Use
22
Switching monitors with a
Base
Do you have Strips or the Base?
This chapter applies to patients with the BodyGuardian
Base. If you are using BodyGuardian Strips, see Chapter 5.
?
Wear one of the monitors while the other one remains in the
charging cradle. Switch the monitor on your chest:
• In the morning after you wake up
• At night before you go to bed
• During the day if the battery is low
Removing a monitor from the Base
You can switch monitors without removing the electrodes from
your body. You do not need to perform any tasks on the phone
when switching monitors.
1. Hold the electrodes against your skin.
2. Unsnap the Base with monitor attached from the
electrodes on your chest.
3. Unsnap the monitor from the Base, then snap the
monitor into the plugged-in charging cradle.
Do not pause or power off the monitor.
The monitor will automatically power off when it is
done transferring data.
Note: Base is reusable for the duration of your study.
6
23
Switching monitors with a Base
Attaching a charged monitor to the Base
Remain near the phone when switching monitors. You can
attach the fully charged monitor while the other monitor is in
the charging cradle and transferring data before it powers off.
1. While off your body, snap the fully-charged monitor to
the Base.
2. Snap the Base, with the fully-charged monitor attached,
to the electrodes on your chest.
3. Power on the monitor by pressing and releasing the
center button. Do not hold the button down.
4. If prompted by the smartphone, select the location
where you positioned the monitor on your chest.
Replacing the electrodes
Change the electrodes when they no longer adhere to your
skin. Electrodes are disposable.
1. Slowly peel back and roll the adhesive away from your
chest.
2. Dampen with water to ease removal from your skin or
remove while in the shower.
Do not rip or tear off the electrodes quickly.
Improper removal may cause skin irritation.
3. Snap new electrodes to the Base.
BodyGuardian Heart Instructions for Use
24
Daily usage
Wear your monitor as you go about your normal daily activities,
as well as at night while you sleep. However, at times you need
to remove the monitor from the Strip (or Base), or remove
both the monitor and Strip (or Base and electrodes).
Remove only the monitor (or monitor and Base) when:
• Showering, bathing, or swimming
• Traveling on aircraft
Remove both the monitor and Strip (or Base and
electrodes) when:
• Undergoing an MRI
Showering, bathing, or swimming
Remove the monitor from the Strip (or the monitor and
Base) when you shower, bathe, or swim. The monitor and the
smartphone are not waterproof, but the Strip (and Base and
electrodes) are.
1. Remove the monitor from the Strip. For Base users,
remove the Base and monitor from the electrodes.
2. Tap Pause on the phone.
3. When you are ready to put the monitor back on, dry off
your skin and the Strip (or electrodes) completely.
4. Snap the monitor to the Strip. For Base users, snap the
Base and monitor to the electrodes.
5. On the smartphone, tap OK to resume monitoring.
6. Verify that the status changes to Monitoring.
Traveling on aircraft
Do not wear the monitor when traveling on aircraft.
7
25
Daily usage
Power off your monitor by snapping it into the plugged-in
charging cradle. This will automatically power off the monitor,
though not necessarily immediately. You can also manually
power off the monitor.
To manually power off the monitor:
1. Press and hold down the center button for at least 15-
20 seconds until the green light is no longer ashing.
You will know the monitor is off when no lights are
ashing every 10 seconds.
Undergoing an MRI
If you are undergoing an MRI, you must remove both the
monitor and the Strip (or the monitor, Base, and electrodes).
1. On the phone, tap Pause.
2. Remove the monitor, then the Strip (or Base and
electrodes).
Cleaning the monitor
If you see visible dirt on the monitor:
1. Use a sterile 70% isopropyl alcohol (IPA) pad and
thoroughly wipe in a circular motion, for a minimum of
30 seconds, all outer surfaces of the monitor. Ensure
excess alcohol does not run into or collect in seams or
crevices.
2. Allow the monitor to air dry.
3. If visible soil remains, repeat steps 1-3 using a new,
sterile IPA pad until the monitor is visibly clean.
Storing the monitor and charging cradle
Store the monitor on the charging cradle when not in use or
for long-term storage. During travel, store the charging cradle
with the snap terminals facing down to prevent moisture or
particulate from entering the terminals.
BodyGuardian Heart Instructions for Use
26
BodyGuardian Heart
monitor lights
The monitor lights indicate status of the monitor only. They do
not indicate anything about your health.
KEY
Slow ash light blinks every :10 seconds
What does this mean?
Off. Press center button to power on.
When plugged into charger:
FULLY CHARGED
Charging.
Battery is low. Switch to other monitor and
charge this one.
Actively monitoring cardiac data.
Checking skin contact and phone connection.
Stay within 3 feet of phone.
Attempting to communicate with phone.
Phone may be out of range.
Strip or Base electrodes do not have good
contact with skin.
Power on sequence. Stay within 3 feet of
phone.
Fast ash light blinks every :02 seconds
8
27
Indications for Use Intended Use
Indications for Use
Intended Use
Indications for Use (US)
The BodyGuardian System detects and monitors cardiac
arrhythmias in ambulatory patients, when prescribed by a
physician or other qualied healthcare professional. Not for
use with patients requiring attended, in-hospital monitoring for
life threatening arrhythmias.
The Preventice BodyGuardian Remote Monitoring System
is intended for use with adult patients in clinical and nonclinical settings to collect and transmit health parameters
to healthcare professionals for monitoring and evaluation.
Health parameters are collected from a variety of commercially
available, external plug in devices such as ECG sensors, weight
scales, blood pressure meters and pulse oximeters.
The Preventice BodyGuardian Remote Monitoring System
does not provide any diagnosis.
Intended use (EU / AU)
The BodyGuardian Heart Remote Monitoring System detects
and monitors biometric parameters in ambulatory patients,
when prescribed by a physician or other qualied health care
professional. BodyGuardian Heart continuously records, stores
and periodically transmits the data for review, storage, or
further processing.
9
BodyGuardian Heart Instructions for Use
28
Warnings / Precautions
Warnings
• Patients with known skin allergies or hypersensitivities
to adhesives or hydrogel may experience reactions.
Patients should consult with their health care professional
to select a BodyGuardian Strip or alternate electrode
option that is most appropriate for their needs.
Precautions
• Apply the Strip or electrodes only to intact, clean skin. Do
not apply over open wounds, lesions, infected or inamed
areas.
• Do not use lotions, oils or sprays on skin location where
you will apply the Strip or electrodes.
• This device is for single patient use only.
• BodyGuardian Heart is not intended for infants
weighing less than 10 kg.
• Do not dispose of the monitors. Return monitors to
your health care provider.
• Do not use a monitor if the casing is broken or
damaged.
• Do not disassemble the monitors.
WARNING: Do not modify this equipment without
authorization of the manufacturer.
• United States federal law restricts the device to sale by
or on the order of a licensed practitioner or therapist.
• Exposure of the wireless communications features of
the device, or its accessories, may be interfered with by
other devices that operate on the same frequencies.
• Monitors are not debrillation proof.
• Do not touch the connectors of the power supplies
while wearing BodyGuardian Heart.
10
29
Appendix A: Specifications & symbols
Appendix A: Specifications
& symbols
BodyGuardian Heart monitor specifications
Expected Service Life 2 years
Battery Capacity 350mAh minimum
380mAh typical
Battery Charger Power Requirement 100-240 VAC, 50-60 Hz
Battery Type Rechargeable Li-ion
Battery Voltage 3.7 VDC
Operating Temperature +10°C to +45°C
Storage Temperature (Power Off) -10°C to +30°C
Operating Humidity 10% to 95%
Storage Humidity 30% to 75%
(excluding condensation)
Operating / Storage Pressure 700-1060 hPa
ECG
• Sampling Rate
• Digital Resolution
• Input Dynamic range
• Input Offset Dynamic Range
256Hz
12 bit
±10mV
±300mV
Sampling Rates
• ECG
• Impedance
• Accelerometer
256Hz
32Hz
10Hz
Measurement Ranges
• Heart Rate
• Impedance
• Respiration
• Activity
25 to 240 bpm (±2 bpm)
0 to 120 Ohms
0 to 30 breaths/min (±1 breaths/min)
±2g range in x,y,z directions
Data Storage
• Capacity
• Type
24-hour continuous
Internal NAND Flash
Weight 35g
Communications Type Bluetooth between monitor and
phone
BodyGuardian Heart Instructions for Use
30
BodyGuardian Heart monitor symbols
Refer to instruction manual.
Type BF applied part; denotes device is not in direct contact
with cardiac muscle.
Wireless transmission symbol
Lot number
SN Serial number
REF Catalogue reference
IPX4 Water splashing against the enclosure from any direction
shall have no harmful effect.
Rx only US law restricts the device to sale by or on the order of a
licensed practitioner or therapist.
Do not dispose of in trash.
Class II equipment
31
Appendix B: Electromagnetic environment
Appendix B:
Electromagnetic environment
The BodyGuardian Heart monitor is suitable for use in the specied
electromagnetic environment. The purchaser or user of the monitor should
assure that it is used in an electromagnetic environment as described below:
Emissions
Emissions test Compliance Electromagnetic Environment
RF emissions
CISPR 11
Group 1 The monitor uses RF energy only for its internal
function. Therefore, the RF emission is very low
and not likely to cause any interference in nearby
electronic equipment.
RF emissions
CISPR 11
Class B The monitor is suitable for use in domestic
establishments and in establishments directly
connected to the low voltage power supply
network which supplies buildings used for
domestic purposes.
Harmonic
emissions
IEC 61000-3-2
Class A
Voltage
uctuations/
icker
emissions
IEC 61000-3-3
Complies
BodyGuardian Heart Instructions for Use
32
Immunity
Immunity Test IEC 60601-
1-2 Test
level
Compliance
level
Electromagnetic Environment
Electrostatic
discharge
(ESD)
IEC 61000-4-2
6 kV contact
8 kV air
IEC 60601-1-2
Test level
Floors should be wood,
concrete or ceramic tile.
If oors are covered with
synthetic material, the relative
humidity should be at least
30%.
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for
power
supply lines
1 kV for
input/output
lines > 3 m
IEC 60601-1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment.
Surge
IEC 61000-4-5
1 kV
differential
mode
2 kV
common
mode
IEC 60601-1-2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment.
Voltage
dips, short
interruptions
and voltage
variations on
power supply
input lines
IEC 61000-4-11
0% Un for 0.5
cycles
40 % Un for 5
cycles
70 % Un for
25 cycles
0 % Un for
5 s
IEC 60601-1-2
Test level
Mains power quality should be
that of a typical commercial
or hospital environment. If the
user of the monitor requires
continued operation during
power mains interruptions,
it is recommended that the
monitor be powered from an
uninterruptible power supply
or battery.
Power
frequency
(50/60 Hz)
magnetic
eld
IEC 61000-4-8
3 A/m IEC 60601-1-2
Test level
Power frequency magnetic
elds should be at levels
characteristic of a typical
location in a typical commercial
or hospital environment.
33
Index
Index
000 1
112 1
911 1
air travel 24
Base iv
attaching charged monitor to
23
removing monitor from 22
switching monitors 22
bathing 13, 24
battery
monitor 20, 22
BodyGuardian Connect 12
BodyGuardian Heart
how it works 3
overview 1
BodyGuardian Heart monitor
attaching to Strip 6
attaching to your chest 7
battery 20, 22
cleaning 25
lights 26
removing from Base 22
removing from Strip 20, 22
status 15
storing 25
switching 20, 22
chest placement location
alternate 9
incorrect 10
preferred 9
do not disturb 13
electrodes iv
replacing 23
kit checklist iv
lights
monitor 26
monitoring
status 14, 15
MRI 13
pause 13
precautions 28
preparing your skin 7
showering 13, 24
skin allergies 28
smartphone
BodyGuardian Connect 12
charging 11
out of range 11
screen dim 12
using 11
Strip
attaching monitor 20
removing monitor 20, 22
replacing 21
swimming 13, 24
symptoms 17
recording
automatically 18
manually 18
warnings 28
Preventice Technologies, Inc.
3033 41st St NW
Rochester, MN 55901
mrdcompany s.r.l.
Viale dell’Unione Europea 8
21013 Gallarate (VA) Italy
For manufacturer comments or concerns:
866-712-6678
507-218-3437
Australian Sponsor
Emergo Australia Level 20 Tower II
Darling Park 201 Sussex Street
Sydney, NSW 2000 Australia
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