Body Guardian Mini Plus Preventice Solutions Patient Instruction Manual

Body Guardian Mini Plus Preventice Solutions Patient

FULLY WATERPROOF
Featuring a waterproof monitor safe for showering, bathing, and submerging in water as deep as 3 feet.

INTRODUCTION

Welcome to

Your physician has prescribed you the BodyGuardian Mini PLUS 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.

Did you receive your monitor at home?
If you are receiving the monitor at home and require assistance, call Preventice Services at:
888.500.3522 (press 1, 2)

When your study concludes
Remove BodyGuardian Mini PLUS 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.

CONTACT INFORMATION

Patient services
888.500.3522 (press 1, 1)
24 hours a day, 7 days a week
monitortroubleshooting@preventice.com

Returning your monitor
888.500.3522 (press 1, 5)
7:00 a.m. – 7:00 p.m. CST, M-F
monitorrecovery@preventice.com

Billing assistance
888.747.4701
8:00 a.m. – 5:00 p.m. CST, M-F
reimbursementinfo@preventice.com

Patient benefit quotes
888-747-4760
8:00 a.m. – 4:00 p.m. CST, M-F
patientbenefitquotes@preventice.com

General information
www.preventicesolutions.com/patients/body-guardian- mini
For the manufacturer’s Instructions for Use, visit: www.preventicesolutions.com/docs/MINIPLUS- IFU.pdf

Instructional videos with subtitles to help you use your monitor are available on the BodyGuardian smartphone. On the BodyGuardian phone, tap Help & Settings → Videos

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 phone cannot be used to make phone calls, including calls to 911, or perform other smartphone functions. Viewing the phone is prohibited while driving, operating heavy machinery or in situations that may jeopardize your safety.

INTRODUCTION

Overview of your monitoring prescription

Equipment

GETTING STARTED

1. Prepare your skin
   You can wear BodyGuardian Mini PLUS either vertically or horizontally.

2. If hair is present, remove the hair where you will place the monitor.

3. Use soap and water to clean the area. Dry the area completely.

4. Do not apply lotions, oils, or perfumes. Do not use alcohol wipes.Do not abrade the skin.
   Decide which chest placement you will use before you prepare your skin.

5. Snap the ECG electrodes to the Bridge
   Press the ECG electrodes firmly onto the Bridge until you hear a snap.

Attach the monitor to the Bridge
Slide the monitor into the black molding on the Bridge until the micro-USB connector is inserted completely into the monitor.
Tips

• This is most easily accomplished on a flat surface, like a table.
• To line up the micro-USB connector with the port on the monitor, you may need to wiggle the monitor slightly to align.
• To ensure a good connection, pinch together with thumb and index finger:

Attach to your chest

1. Peel away backing from the electrodes to expose the adhesive.

2. Place on chest in one of the placement locations (pages 9-10).
   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 electrode option.

3. Press firmly around the surface of the electrode to ensure adhesion to the skin.

Preferred placement (vertical)

Place the top of the Bridge just below the jugular notch, at the base of the neck at the intersection of the collar bone.

Alternate placement (horizontal)
Place the right side of the Bridge near the center of the chest over the sternum.

Turn on phone
Press and hold the Power key located on the right edge or the back of the phone, depending upon the model. Once powered on, the phone displays the ACTION REQUIRED screen.

Turn on monitor
Press and release the center button on the monitor once. As the monitor successfully powers on, it beeps periodically as it connects to the phone.

How do I know if the monitor is on?

Visual indicator
An LED light on the monitor blinks every 5 seconds. The monitor is designed to be unobtrusive, so the lights are faint. They can best be detected in a dark or dimly lit room.

Audible indicator
If you cannot detect the blinking LED light on the monitor, press and release the center button. One beep indicates that the monitor is on. Three beeps indicate that the monitor was off, but is now powering on.

Success
Stay within 3 feet of the phone, remain still, and wait for the phone to display a status of Monitoring.

DAILY USAGE

Tip The smartphone supports multiple languages. Tap Help and Settings → Settings → Change Language.

Keep the phone within 10 feet of the monitor on your chest
Keep the phone with you at all times.
However, if (1) you get separated from the phone or (2) the phone battery depletes,the monitor will continue to collect data and automatically send it to your health care  provider when the phone is back in range of the monitor.

If the phone moves out of cellular network range . . .
Your monitoring will continue uninterrupted, but your data won’t be sent to your health care provider until you are back in cellular range.
Move to a location with a better cellular signal at your earliest convenience.

Charge the phone nightly

Ensure the phone is within 10 feet of the location where you sleep. Leave the phone turned on and plug it into the phone charger and into a wall power outlet.
The phone displays its battery status as pictured at left.

Note: If you don’t want to be disturbed by alerts while sleeping or while at an event, tap Do Not Disturb on the phone.

Wi-Fi
You can connect the phone to an available Wi-Fi network. This can be particularly useful if you find yourself in an area of poor cellular coverage.

1. On the home screen, tap Wi-Fi.
2. Ensure the Wi-Fi button is toggled to ON.
3. From the list displayed, tap a network that you trust, then enter the password (if required).

Record 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 monito
   After pressing the button, it can take up to 60 seconds for the symptoms prompt to appear on the phone.

2. Hold as still as possible for 60 seconds.

3. On the phone, 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.

Switch monitors when battery is low
Switch the monitor on your chest when the battery is low. The phone will alert you when your monitor battery is low.
Always wear one of the monitors while the other monitor remains connected to the charger.

You do not need to remove the Bridge from your chest to switch monitors.

1. Detach the monitor from the Bridge on your chest
   Do not pause or power off the monitor.
   The monitor will automatically power off when it is done transferring data and charging.

2. Firmly plug the charger into monitor You must plug the charger into the monitor you just removed from your chest before you attach the other, fully-charged monitor onto your chest.
   Do not use your own personal device chargers. Only use the charger(s) provided.

3. Attach the charged monitor to the Bridge
   (see page 7 for more detail)

4. Power on the monitor on your chest

5. Press and release the center button on the monitor.
   Do not hold the button down.

6. Remain near the phone when attaching the fully-charged monitor.

7. The phone will automatically detect the new monitor.

Charging the monitor
When the monitor battery is low, the phone will alert you (see page 18).
If this occurs, switch your monitors.

Do not use your own personal device chargers. Only use the charger(s) provided.

• While charging, the blue light on the monitor will blink.
• Once fully charged, the blue light will remain solidly lit.

Replacing the ECG electrodes
Change the ECG electrodes every 3 days OR when they no longer adhere to the skin.
Electrodes are disposable.

1. Remove the monitor and Bridge 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.

3. Re-attach BodyGuardian Mini PLUS to your chest (see pages 8-10).
   Do not rip or tear off the electrodes quickly. Improper removal may cause skin irritation.

Showering, bathing, swimming
The Bridge, monitor and ECG electrodes are waterproof and can safely be submerged in water as deep as 3 feet.

The phone is NOT waterproof. Keep away from water.

• You do not need to remove BodyGuardian Mini PLUS when showering or bathing.
• If you will be swimming in water deeper than 3 feet, remove the monitor.

After showering, bathing, swimming while wearing BodyGuardian Mini PLUS:

1. Pat the Bridge with a towel to dry it off.
2. Press and hold the electrodes against your chest to ensure good contact with your skin.

MRI
BodyGuardian Mini PLUS cannot be worn while undergoing an MRI.

1. On the phone, tap Pause Monitoring.
2. Remove Bridge, monitor and electrodes from chest.
3. After the MRI, snap new electrodes to the Bridge and re-attach to your chest (see pages 8-10).
4. Tap Resume on the phone.

Air travel
BodyGuardian Mini PLUS is safe to wear while traveling on aircraft. You do not need to remove the monitor.
If you will be traveling on aircraft:

1. Contact Preventice prior to departure to document dates of travel.
2. Power off phone after boarding.
3. Power on phone after landing.

Monitor indicators

This section explains the sounds and LED lights on the monitor. The phone communicates this same information and is the best method for understanding the status of your monitoring session.
If you are curious about what the monitors sounds and lights mean, you can use this information as a reference.

Note The monitor lights are faint. They can best be detected in a dark or dimly lit room.

Errors

After 12 seconds, the monitor lights will flash once,followed by a long beep.

COMPLETING YOUR MONITORING

When your prescription ends

The phone will alert you when your prescription has ended.
When you see this message on the phone:

1. Remove the monitor on your chest, then place it near the phone.
   Do not power off the monitor.

2. Power on the other monitor and leave it near the phone.

3. Wait for the monitors to power off. The monitors will power off automatically once they are done sending data. You will know the monitor is off when none of the four lights are lit.

4. Power off the phone.

5. Pack up and return your equipment (see page 21).

Return your equipment immediately after your service ends
If you are returning your equipment to your health care provider:

1. Follow the instructions provided by your health care provider.

If you are returning your equipment to Preventice Services:

1. Place the powerered-off monitors into the foam pouch provided, then into the original postage-paid box. Then place the phone, charging cord, any unopened Bridges and ECG electrodes, and patient survey into the box.
2. 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.
3. 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.

TROUBLESHOOTING

Poor Skin Contact message appears on the phone

CAUSE
This message indicates poor contact between your skin, the monitor and Bridge (or electrodes). It is NOT related to the Bluetooth or cellular connection of the phone.

RESOLUTIONS

1. Tap OK
   Tap OK on the phone to dismiss the message.

2. Check the monitor attachment
   Ensure the monitor is securely attached to the micro-USB connector.

3. Check the chest application

   • 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.

   • Chest placement location
     Ensure that BodyGuardian Mini PLUS is positioned properly on the chest. See pages 9-10 for chest placement locations.
     Tip: For the horizontal Bridge position, some patients acquire a better signal when the monitor is placed higher up on the chest, closer to the collarbone, to avoid fleshy tissue areas. BodyGuardian receives a higher quality signal when placed over firmer areas.

   • Skin preparation
     Ensure that the skin on the placement location on your chest has been prepared appropriately:

   • Remove hair, excess oils, lotions, perfumes, etc.

   • Use soap and water to clean the area. Do not use alcohol wipes. Dry the area completely.

   • Do not abrade the skin.

4. Replace the ECG electrodes

5. Ensure that the chest placement location is properly prepared. See 3c. Skin preparation.

6. See page 16 for instructions on replacing the ECG electrodes.

When switching monitors, the phone displays PREPARING MONITOR 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 phone.

RESOLUTION
Wait for the phone to finish downloading.

1. Keep the phone within 3 feet of both monitors to allow the downloading process to complete.
2. Once the phone has finished downloading, the status on the phone will change to Monitoring. This may only take a few minutes, but could take up to an hour, depending on the amount of data to be downloaded from the monitor to the phone.

The phone touch screen dims or shuts off automatically

CAUSE
Even when the phone is collecting data, the phone turns off the touch screen to conserve battery when you do not use the phone for a specified period. This is normal. The phone is still performing its monitoring functions. It has simply turned off the touch screen display.

RESOLUTION
No action is necessary. If you would like to wake the phone screen:

1. Press the Power key located on the right edge or the back of the phone, depending upon the model.

A number pad prompting for a passcode appears on the phone

CAUSE
The phone may display a security passcode screen.

RESOLUTION
This screen can be dismissed.
Tap the white arrow in the upper-left corner of the screen.

INSURANCE INFORMATION

Patient financial obligations and billing information

On behalf of your physician, you are being provided with a heart monitor from Preventice Services. This study 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 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 monitoring prescription 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 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: www.preventicesolutions.com/patients/patient- survey.html

Patient name City State
Doctor’s office / hospital
My hook-up took place at: Home
Contact me via: Phone Physician’s office

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

L-28_PIM-BGMP02EN_Rev 5.0 Copyright © 2020 Preventice Solutions – All rights reserved.

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