Cyberonics PG1000TRX User Manual
Caution: Investigational device. Limited by Federal law to investigational use.
March 2014
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Table of Contents – ProGuardianRESTTMSystem User Manual
Section Page
1. Introduction 4
2. Understanding Your ProGuardian System 4
2.1System Components 4
3. Intended Use 5
4. Cautions 5
5. Contraindications – Use Restrictions and Limits 6
6. Before You Start Using Your ProGuardian System 6
6.1Explanation of Symbols 7
6.2Cleaning, Storage, and Handling 8
7. Setting Up Your ProGuardian System 9
7.1Hub Setup 9
7.2Setup Wizard for Hub Software 12
7.2.1How to Enter Information on the Hub 13
7.2.2Starting the Setup Wizard 13
7.3Begin Seizure Monitoring 14
7.3.1Preparation 15
7.3.2Sensor Patch Setup 16
7.3.3Patch and Sensor Application 18
8. Responding to Seizure Notifications 20
8.1Confirmingor Denying a Seizure Notification 21
8.2Adjusting Seizure Notification Sensitivity 21
9. Pausing or Stopping Monitoring 22
9.1Pausing and Resuming Seizure Monitoring 22
9.2Turning Seizure Monitoring Off 23
10. Replacing the Patch 25
11. Using the Hub Software 26
11.1Home Screen 26
11.1.1How to Lock the Hub 26
11.2Sensor 27
11.3SeizureLog 27
11.3.1Navigating the Seizure Log 28
11.3.2Adding Seizures to the Log 28
11.3.3Removing Seizures from the Log 28
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Section Page
11.4Reports Menu 29
11.4.1Create a Report 30
11.5System Status 30
11.5.1Connectivity Tab 31
11.5.2Sensor Tab 31
11.5.3Hub Tab 32
11.6Settings Menu 33
11.6.1Seizure Detection Settings 33
11.6.2Sound Settings 35
11.6.3Display Settings 36
11.6.4Date and Time Settings 37
11.6.4.1Changing Date and Time 37
11.6.4.2Date and Time Formats 37
11.6.5Patient Profile 38
11.6.6Account Information 38
11.7Help Menu 39
11.7.1ProGuardian App Setup Wizard 39
11.7.2About 40
11.7.3Contact Us 40
11.7.4Administrator Access 40
12. The ProGuardian App 40
12.1ProGuardian App Setup Wizard 41
12.2Wi-Fi Network Changes and Registering New Devices 45
12.3Receiving Notifications on Your Mobile Device 46
12.4Adjusting Your Mobile Device Sound Settings 47
12.5Configuring App Sound Settings 48
12.6Discontinuing Use of the ProGuardianApp 48
13. Troubleshooting 49
13.1Sensor Reset 49
13.2Common Error Messages 50
13.3Replacing a Lost or Damaged Sensor or Hub 55
14. System Specifications 55
15. FCC Compliance Statement 56
16. Contact Us 57
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What it is.
What it looks like.
What it does.
Hub with power cordand
country specific adaptor(s)
(PG1100)
Provides a notification
when a potential seizure
is detected.
Seizures that are
confirmed by youare
stored in the seizure log.
Patches
(PG1200)
(Single use, disposable)
(30, individuallypackaged)
Adheres theSensor to the
body while sleeping.
1. Introduction
The ProGuardian System is used to sense changes in heart rate ormovement during periods of sleep in
people with epilepsy. Whena potential seizure is detected, the ProGuardian System sends out an audiovisual notification.
When you—the Caregiver—confirm these notifications, the System compiles them into summary
reports. The reportsallowyouto track seizure activity over time and can be used when talking to your
health care provider.
While helpful in detecting potential seizure activity, the ProGuardian System is not intended to replace
Caregiver supervision or prescribed healthcare. The ProGuardian System is an informational tool that
may help you enhance your efforts in managing your loved one’s epilepsy.
2. Understanding Your ProGuardian System
Your ProGuardian System comes with the components listed below. If anything is missing or damaged,
contact your Customer Care Service Center (refer to Contact Us section of this manual).
2.1. System Components
These items are included in your ProGuardian System kit:
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What it is.
What it looks like.
What it does.
Sensor
(PG1000)
(Body worn)
Collects heart rate and
movementinformation
while sleeping.
ProGuardian Application
(Accessory)
Can be downloaded from
www.ProGuardianSystem.com
Receives notifications on
an Android mobile
devicewhile away from
the Hub (active when
connected to home Wi-Fi
Network).
USB Flash Drive
(Picture may not represent actual item)
Transferssummary
reports from the Hub.
No component of the ProGuardian System is provided sterile, or made with natural rubber latex.For
additional information about the System, please see Section 14,System Specifications.
3. Intended Use
The ProGuardian System is a monitoring device for people with epilepsy five years of age and over. The
system aids in detecting, notifying, and recording potential seizures during periods of sleep.It is capable
of detecting seizures that are accompanied by changes in heart rate or movement.
4. Cautions
Follow these Cautions to avoid the possibility of harm to the user or damage to the device.
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The ProGuardian System will not detect all seizures and is not intended as a life-saving device.
Talk to your healthcare provider (HCP) immediately if you have any concerns or if the condition
of the person with epilepsy worsens.
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Do not rely on the seizure notification feature for delivery of life sustaining medical treatment,
such as administration of rescue medication.
If the Hub loses power, the System may miss seizure detections.
If you experience symptoms of skin irritation or allergic reaction such as redness or swelling with
the use of the Patch, remove immediately. If symptoms do not improve or get worse after
removal of the Patch, please consult your healthcare provider.
The ProGuardian System should not be used while undergoing any diagnostic medical
procedures, such as MRI or X-Ray.
The ProGuardian System should not be used in an oxygen rich environment (e.g., oxygen tent,
hyperbaric chamber).
The ProGuardian System should not be used on an airplane.
The ProGuardian System includes radio frequency technology. For complete FCC compliance
information please see Section 15.
Do not drop the Sensor or Hub. Doing so may damage the ProGuardian System.
Only use the power cord supplied with the Hub.Failing to do so can damage the System and
present a fire hazard.
Only use ProGuardian Patches. Other types of Patches will not work with your System.
Do not expose the Patch to fire or heat sources, as it contains a battery that could explode.
Do not expose the Hub, Sensor, and Patch, to water or any other liquid. Doing so may damage
the ProGuardian System.
Dispose of the lithium coin cell battery in the Patch in accordance with local regulations.
5. Contraindications – Use Restrictions and Limits
The ProGuardian System should not be used on anyone who is:
Under 5 yearsof age
Implanted with a cardiac management device (e.g., cardiac defibrillator, pacemaker)
6. Before You Start Using Your ProGuardian System
Read this manual.
To use the System correctly and be most comfortable using it, you need to understand how
it works and be familiar with its screen displays and system features.
Inspect each componentof the System.
If you see any damage to any system components or if you are missing any component, call
your Customer Care Service Center immediately.
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Symbol
Description
Notice for reader to pay special attention to details that follow
Serial number (located on both the Hub and Sensor)
Storage temperature ranges
Batch code (located on patch packaging)
Date of manufacture
Consult Directions for Use
Provides helpful usage tips and guidelines
Complete the Setup Wizard.
You must complete the Setup Wizard before using the ProGuardian System for the first
time. The settings you put into the system are critical for providing accurate and useful
information.
Note:The date and time must be entered correctly in order for seizures to be accurately
recorded in the seizure log.
Understand what the System does.
The ProGuardian System is used to sense changes in heartrate or movement and to
notifyyouof potential seizure activity. The system is not intended to replace supervisionand
should not be expected to detect all types of seizures.
6.1. Explanation of Symbols
The symbols below are used in the manual, in other package labeling, or on the product components
forthe ProGuardian System.
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Symbol
Description
Manufactured by
Authorized Representative
RF-enabled
Do not put in regular trash. Requires special disposal.
Single Use
Storage humidity limitation
Bluetooth-enabled
Type BF medical device
Storage and use atmospheric pressure limitation
Class 2 medical device
Ingress protection ratingfor allowable exposure to moisture and
dust
6.2. Cleaning, Storage, and Handling
As with any device, proper storing and handling guidelines should be followed to ensure the
ProGuardian System operates most effectively. Follow the guidelines listed below.
When handling the ProGuardian System, make sureyou have dry, clean hands.
Do not exposethe Hub, Sensor, and Patchto water or any other liquid.
Operate the System in temperatures ranging 5- 40°C (41- 104°F) and 15-93% relative humidity.
When not in use, the System can be stored in temperatures ranging -25 - 70°C (-13 -158°F) and
15- 93% relative humidity.
Each Patch contains a small battery. Dispose used patches in compliance with local regulations
for lithium coin cell batteries.
Do not cover the Hub, as this could result in over-heating.
Do not place the Hub near equipment that generates heat.
Use a soft damp cloth to clean the Hub display and Sensor. Do not use harsh chemicals or
abrasives.
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Do not open individual Patches until needed. Doing so may cause the adhesive to be less
effective.
If you need to dispose of the Sensor or the Hub, please return the device back to Cyberonics.
7. Setting Up Your ProGuardian System
This section instructs you on how to set up the Hub and Sensor so you can begin using your system. The
ProGuardian System also works with an optional ProGuardian App thatcan be activated during initial
setupor configured at a later time (see Section 12, “The ProGuardian App”for more details).
To begin using your ProGuardian System,set up the following parts of the system:
Hub
Hub Software
Sensor and Patch
7.1. Hub Setup
The Hub is where you enter and receive information. When set up with an active Sensor, it provides
anotification when a potential seizure is detected. Confirmed seizures are stored in the seizurelog.
Follow the steps below to set up the Hub. The Hub must be placed at least 5 feet (1.5 meters) away
from the sensor wearer’s support system (such as a bed or couch) when he or she is sleeping (Figure 1).
Figure 1: Hub Placement
1. Become familiar with the buttons and LED locations on the Hub (see Figure 2, Figure 3, and
Figure 4).
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Figure 2: Hub Front
Figure 2:
A -Connectivity LED – Provides a visual indicator for the System connectivity:
Blue: No connectivity issues exist while connected to the Sensor.
Solid amber: Either the Hub-to-Sensor or Hub-to-ProGuardian App communication is
disrupted (when enabled).
Flashing amber: During Sensor setup or anytime the System is paused.
Not lit: When the neither the sensor nor the Caregiver App are registered or
connected.
B – Notification LED – Provides a visual indicator for notifications:
Flashing amber:Indicates pending seizure or system notifications.
Solid amber:A system notification has not been resolved after warning message has
been dismissed.
C – Power Button – Press and hold to turn Hub ON or OFF. Blue when the Hub is turned ON.
Tap button to turn screen ON and OFF while system is still active.
D – Home Button – Press to return to the Home Screen from any software screen.
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Figure 4: Hub Bottom
Figure 4:
A –Power Alert
Battery
B – Hub Reset
C – AC Plug
D – USB-2 Port*
E – USB-1 Port
F – LAN*
*Not active
A B A E F D C
B
Figure 3: Hub Back
Figure 3:
A –Silence Button – Flashes amber to provide a visual indicator of a pending seizure
notification. Press to silence audio during seizure notifications. You must tap Confirm or
Deny on the touchscreen to dismiss the notification displayed on the Hub.
B –Power Alert Off – The Hub provides an alert if the wall outlet is disconnected or if it loses
power for any reason while turned ON. This button silences the alert.
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2. If this is your first time using the System, remove tab from the power alert battery compartment
(see Figure 5).
Figure 5: Remove Tab
3. If required, assemble the AC adaptor with the appropriate plug tip (seeFigure 6).
Figure 6: Assemble AC Adaptor
4. Connect the power cordinto the back of the Hub, and then plug into a wall outlet.
5. The Hub will automatically turn on, display the Cyberonics’logo, and start the ProGuardian
software.
7.2. Setup Wizard for Hub Software
The Setup Wizard guidesyou through the registration and initial setup of the Hub software. Follow the
on-screen instructions andenter the requested information.
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Option
Description
Pop-up Menu
Tap a setting field to view a pop-up menu of available options.
Tap an option to select it.
Text Field
Tap the empty text field to pull up an on-screen keyboard.
7.2.1. How to Enter Information on the Hub
Use the following methods to enter information as prompted by the Setup Wizard and during normal
use of theHub software.
7.2.2. Starting the Setup Wizard
To start the Setup Wizard, follow the on-screen instructions listed below.
1. If you have not already accepted the Terms of Service, read the agreement and press the
“Accept” button. You must accept the Terms of Service before using the ProGuardian System.
2. Press the “Next” button to begin system setup (Settings & Registration).
3. Select the preferred date and time format by selecting a field and using the Pop-up menu. Press
the “Continue” button after making your selections.
You may select the order in which day, month, and year is displayed and recorded by
the System.
You may choose either 12 or 24 hour clock format.
4. Enter the correct local date and time. These settings must be accurate so that when seizure
detections are added to the log, the date and time information is correct.
a. To set the date, tap the current date.
b. Adjust the date by using the “+” and “-” buttons, or by using the on screen keyboard to
type into the year, month, or day fields.
c. Press “Ok” when finished.
d. To set the time, tap the currently displayed time setting.
e. Adjust the time by using the “+”and “-” buttons, or by using the on screen keyboard to
type into the hour and minute fields. AM and PM can be selectedby tapping the field
(when appropriate based on selected time display format).
f. Press “Ok” when finished.
g. Press “Continue” after both the time and date are set.
Note:To adjust these settings at a later time refer to the “SETTINGS MENU” section.
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5. Enter the sensor wearer’s name and date of birth by tapping the text field and using the on-
screen keyboard or popup menus. This information will be included on reports created by the
System. Press “Continue” when finished.
6. Create a password and a security question used to recover your password should you forget it.
All entries can be completed by tapping the text field and using the on-screen keyboard or
popup menus. Press “Continue” when finished.
a. Passwords are case sensitive (upper and lower case letters are checked) and must
consist of numbers, letters, or symbols (no spaces allowed). They must be at least 5
characters long.
b. The security answer is not case sensitive.
c. To adjust these settings at a later time, refer to the “SETTINGS MENU” section.
7. “Settings and Registration” is complete, press “Next” to proceed.
8. (OPTIONAL)
You can setup the ProGuardian App at this time; or, you can later access the ProGuardian App
Setup Wizard from the Home Screen Help menu.
a. The ProGuardian App is an optional mobile applicationthat can be loaded on anAndroid
smart phone.
b. The application allows receipt of seizure notifications from the Hub on your mobile
device when in range of your home Wi-FiNetwork.
c. Refer to the “The ProGuardian Mobile Application” section for more details.
You have successfully completed the Hub software Setup Wizard.
When ready to begin seizure monitoring, complete the steps listed in “Begin Seizure Monitoring”.
7.3. Begin Seizure Monitoring
The Sensor is a body-worn device that collects heart rate and movementinformation. The Patch is a
single-use, disposable adhesive stripthat connects to the Sensor and adheres to thebody.The Patch has
gel components that allow the Sensor to detect a heart rate. It is important that the Patch is in full
contact with the skin to give accurate information to the Sensor and Hub.
The System is intended for seizure monitoring during sleep, andPatches may be worn for up to 12 hours
before replacement is necessary.
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7.3.1. Preparation
The assembled Sensor and Patch should be worn in one of the following locations on the body (Figure
7):
Figure 7: Areas for Skin Preparation
Figure 7:
A - Left chest (Preferred position)
B –Lower Left rib cage
C - Left back – directly below the shoulder blade (Least preferred position)
*Positions of Patch can be rotated by any degree; however, ensure center of Patch (indicated by
) is placed as shown on diagram.
Caution: For people with the implantable VNS Therapy® System, the ProGuardian Sensor
should only be placed on the lower rib cage or on the back.
To ensure the sensor has fullcontact with the body, prepare the skin by following the steps below.
1. Trim any excess hair from the chosen location using scissors or electric clippers.
Caution: Do not use a razor, as this can cause skin irritation.
2. Clean the area with soap and water to remove oils or lotion.
3. Dry the area thoroughly.
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Caution:The Patch should not be applied to cuts, abrasions, sun burns, rashes, or any
other type of abnormal skin condition. Applying the Patch to skin that is damaged may result in
discomfort, pain, or worsening of the skin condition.
Note:Change the Patch location on a regular basis (nightlyor as needed) to prevent skin
irritation.
Note:Use soap and water to remove residue from a previous Patch.
7.3.2. Sensor Patch Setup
1. Confirm that the Hub is displaying the Home Screen(Figure 8).The Sensor icon on the Home
Screen will begray (disabled) until the System is ready to detect seizures.
Caution: If the Sensor icon is yellow (enabled), then the system was not turned off from
the Hub Home Screen at the end of the last use period. To prevent connection problems, press
the Sensor icon, then select “Off” before proceeding to Step 2 (see “Pausing or Stopping
Monitoring” for more details).
Figure 8: Hub Home Screen (Sensor Inactive)
2. Locate yourSensorand remove asingle disposable Patch from its packaging (Figure 9).
Note:Do not peel the liner away from the Patchadhesive. You will be instructed to expose
the adhesive at a later step before application to the body.
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Figure 9: Open and Remove Patch from Packaging
3. Align the triangle on the plastic Patch connector with the triangle notch on theunderside of the
Sensor (Figure 10).
Figure 10: Align Triangles on Sensor and Patch
Note:The Sensor and Patch can only be connected when properlyaligned. The triangle
notch on the Sensor and triangle on the Patch must face the same direction.
Caution:If moisture is present on or near the back of the Sensor or the contacts of the
Patch, do not assemble. Doing so can permanently damage the System. Dry the parts using a
soft cloth, paper towel, or cotton swab before proceeding.
4. Apply firm pressure to the top and bottom of the Sensor to snap the Patch and Sensor
together(Figure 11). Ensure all four corners of Sensor snap into place.
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Figure 11: Put Sensor and Patch Together
Note:The Sensor’s light blinks green for 10 seconds upon successful connection of the
Sensor and Patch. When you see this, proceed to the next section (Patch and Sensor
Application).If the Sensor LED is red, refer to the Troubleshooting section.
7.3.3. Patch and Sensor Application
1. Remove the protective liner from the Patch and place on the bodywithin 5 minutesafter
connecting the Patch and Sensor(Figure 12).
Figure 12: Remove Patch Liner
2. Apply the assembled Sensor and Patch. The assembled Sensor and Patch should be worn in one
of the following locations on the body (Figure 13):
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