VitalConnect VitalPatch, VistaPhone MKT-198 Rev.C (June 2023) Quick Start Guide

Welcome

This guide describes how to use the VitalPatch^® biosensor and VistaPhone for at-home cardiac monitoring.

• The VitalPatch is worn on the chest to measure and record your vital signs and heart rhythms.
• The VistaPhone sends data from VitalPatch to your care team for monitoring.

Wear the VitalPatch at all times during the monitoring period and keep the VistaPhone near you.

For detailed instructions and warnings, refer to IFU-06,

VitalPatch Instructions for Use and IFU-26, VistaPoint Instructions for Use. You can view these by tapping the Menu button on the VistaPhone and then tapping Help.

Using the VistaPhone

Unpacking and Charging

If you have not already done so, remove the VistaPhone charger and cable from the package labeled "VistaPhone." Keep all packing materials.

Use only the provided USB-C cable and charger for your VistaPhone. Keep the device plugged into the charger at night near your bed while you are sleeping. You can use the VistaPhone while it is charging. Look at the battery indicator in the status bar. Do not let the VistaPhone battery run out.

Turning VistaPhone On and Off

The VistaPhone should always be ON when you are wearing a VitalPatch. The screen will go to sleep (but device will remain ON) after a period of inactivity.

• To Turn ON: Press Power Key until the device vibrates and the screen lights up. To check if ON, tap the screen.
• To Unlock: Swipe across the screen with your finger and then enter PIN code 1234.
• To Turn OFF: Press and hold the Power Key until the Options menu displays, and then select Power Off.

Checking Cloud Connection

Keep the VistaPhone in a place with a strong cell phone signal. If the screen shows Cloud Connection Lost , move the VistaPhone to a location with a better signal, or configure a Wi-Fi connection (see below).

Setting up a Wi-Fi Connection

1. Tap the Menu button and then tap the Applications menu item. Select the Wi-Fi Center application.
2. If Wi-Fi is OFF, tap the Turn ON Wi-Fi button to turn Wi-Fi ON.
3. Tap the name of the network you want to connect to. Enter the Wi-Fi password (if asked) and tap CONNECT.
4. Tap the Back button to exit.
   

If VistaPhone battery runs out

If the VistaPhone battery runs out, cardiac monitoring will be interrupted. To resume monitoring:

1. Plug the VistaPhone into the charger.
2. Turn on the VistaPhone by tapping the power key. Swipe the screen to unlock and then enter the PIN code.
3. Continue charging the VistaPhone.

Applying the VitalPatch

To see an instructional video, tap the Menu button, tap Help, and then tap VitalPatch Application. Or follow the guided help instructions on the VistaPhone screen.

Prepare Upper-Left Chest

1. If a previous VitalPatch is still applied, remove it first (see Removing and Replacing VitalPatch). If there is body hair on the site, shave the site before cleaning. Prepare an area larger than the VitalPatch. See figure below.
2. Clean site with an alcohol wipe and allow to dry.
   

Remove from Pouch and Power-On

1. Tear open pouch at the notch and remove VitalPatch.
2. Allow the VitalPatch to "breathe" for at least 2 minutes before proceeding to the next step.
3. Place VitalPatch on a flat surface. Press and release the power button. A green light below the logo will flash when VitalPatch is powered on (the light will go off).
   

Hold Against Chest

DO NOT remove the backings in this step!

1. Hold the VitalPatch against the chest in the position shown in the figure to the right.
2. Space two fingers below the jugular notch (dip at the base of the neck).
3. Position diagonally with the three lines angled downward away from the midline.

Remove Backings and Apply

DO NOT touch the adhesive with your fingers!

1. Hold one side of the VitalPatch down.
2. Lift the opposite side, and peel the backing off from the center. Press against skin.
3. Peel the backing off from the other side of the VitalPatch.
4. Firmly press down both sides to attach to skin.
   

Optional Adhesive Overlay

If your care team recommends an adhesive overlay, please review the instructional video. Go to the Menu button, tap Help, and then tap VitalPatch Adhesive Overlay.

Wearing the VitalPatch

• DO NOT shower or exercise for 30 minutes after applying the VitalPatch. Showering and exercise are OK after the first 30 minutes.
• DO NOT expose the VitalPatch directly to the shower head, and avoid excessive contact with soap or scrubbing. Gently pat the VitalPatch dry after showering.
• DO NOT swim with the VitalPatch or use in a sauna, steam room or hot tub.
• DO NOT wear more than one VitalPatch at a time. Disconnect and remove the old VitalPatch before applying a new one. See Removing and Replacing VitalPatch for instructions.
• Each VitalPatch will last up to 7 days (168 hours). To preserve data recorded by the VitalPatch, make sure you are connected to the VistaPhone before the VitalPatch expires.
• If discomfort or irritation occurs, the VitalPatch should be removed. Contact your care team immediately.
• If the VitalPatch begins to fall off or lift from the skin, contact your care team immediately.

Pairing VitalPatch with VistaPhone

Begin the Pairing Process

1. If you followed the guided help instructions to apply the VitalPatch, the pairing process will begin automatically. Or tap Connect VitalPatch.
2. Tap Search for VitalPatch ID to search for nearby VitalPatch biosensors. A list of IDs will display.
3. Tap the Bluetooth ID of your VitalPatch. If the Bluetooth ID does not appear, press the power button on the VitalPatch again and tap the Rescan button.

If you see message about a previous patient

The screen may show the message: "A previous patient is associated with the device. How do you want to use the new VitalPatch?" Choose one of the following options:

• If this is the first VitalPatch for this patient, tap the button that says: "Start a new patient with their first VitalPatch."
• If the patient just finished a VitalPatch and is starting a second VitalPatch, tap the button that says: "Keep monitoring the current patient with a new VitalPatch."

Select Patch Position

When the screen asks for the patch position, select the Primary position image and then tap Next.

Select Body Position

When the screen asks for body position, select from:

• Standing or Sitting — Sit or stand upright
• Elevated — Lie on a bed elevated at an angle of 30°.
• Supine — Lie down as flat as possible.

Remain still in the current body position and tap Calibrate.

Note: If the patient walks with the VitalPatch before pairing, some steps of the calibration process will not be displayed. This is expected behavior and the VitalPatch will operate normally.

Daily Activities During Monitoring

Check VitalPatch Hours

To check the status of your VitalPatch, look for the "hours remaining" on the screen. Replace the VitalPatch when it expires or less than 8 hours are remaining.

Check VitalPatch Status

• If the screen shows Vital Signs Not Uploading, make sure the VistaPhone and VitalPatch are near each other.
• If the screen shows Body Contact Not Good, check that the VitalPatch is adhered to the skin. If the patch appears to have lifted off, contact Customer Support (800-219-3000) for additional guidance.

Reporting Symptoms

If you feel a symptom, do the following:

1. When it is safe to do so, unlock the VistaPhone and tap the Report Symptom button.
   
2. From the list of options, tap one or more symptom(s) to select. Tap Other if the symptom is not listed. Tap Next.
3. If you select Other as a symptom, you will be asked to enter a description of the symptom(s). Enter the information and tap Next.
4. Tap the activity level (Low, Medium or High) that you experienced when the symptom occurred. Tap Send Symptom when complete.

Removing and Replacing VitalPatch

Each VitalPatch lasts up to 7 days. If monitoring more than 7 days, disconnect the VitalPatch when less than 8 hours are remaining, and then apply a new VitalPatch.

Disconnect the VitalPatch

1. Tap the Menu button and then tap Disconnect Patch.
2. If you will be applying a new VitalPatch, tap the Disconnect VitalPatch and continue monitoring patient button.

Remove VitalPatch and Overlay

1. If overlay was used, grasp a corner of the overlay and peel it off the skin. Continue pulling the overlay off. Stretch the overlay horizontally to help release it from the skin. The VitalPatch may pull off with the overlay.
   
2. Wipe an adhesive removal pad along the edge of the VitalPatch. Grasp a corner of the VitalPatch and peel off while sweeping the adhesive removal pad underneath.
   
3. Cut the VitalPatch in half with scissors and dispose according to local laws for routine electronic waste.
   

Clean Skin and Apply New VitalPatch

1. Clean skin with an alcohol pad and allow to dry.
2. If your monitoring period is longer than 7 days, apply a new VitalPatch.

Return Equipment

If your monitoring period is finished, return the equipment as soon as possible. Refer to the separate Return Instructions document.

Failure to return equipment may delay test results and you will receive a bill for the cost of the device.

Have Questions or Need Help

Help with VitalPatch, VistaPhone, and General Support, please call 800-219-3000.

Help with Device Returns: Please call the Inventory Team at 877-908-6560.
Help with Service Billing: Please call the Billing Team at 855-621-8250.

CALL 911 if you are having an emergency!

VitalConnect, Inc.
2870 Zanker Road, Suite 100
San Jose, CA 95134
(408) 963-4600
www.vitalconnect.com
support@vitalconnect.com
A list of our trademarks can be found at www.vitalconnect.com. All other marks may be trademarks of their respective companies.