VitalPatch Adhesive Overlay

Indications for Use

The Adhesive Overlay is an adhesive for use in conjunction with the VitalPatch device. This is an optional accessory that may be used when the VitalPatch device does not adhere for the full monitoring session period. Other adhesives or overlays not specifically made for the VitalPatch device are not recommended and could void the warranty of the VitalPatch device when used. Follow the instructions below when applying and removing the Adhesive Overlay.

Warnings and Precautions

The adhesives in this product may cause adverse skin reactions. Healthcare providers should advise patients to seek medical attention if either of the following occurs:

• A severe adverse event.
• An allergic reaction persisting beyond 2-3 days.

If discomfort or irritation occurs, the adhesive overlay should be removed.

Overview

Figures 1, 2, and 3 provide an overview of the adhesive overlay application sites, positioning, and final appearance. Detailed instructions on how to apply the overlay are in the next section.

Figure 1: VitalPatch and Adhesive Overlay Application Sites. This diagram shows the back of a person with two VitalPatch devices placed on the upper back, labeled "Primary Location" and "Secondary Location". Arrows indicate "Right side" and "Left side".

Instructions for Applying the Adhesive Overlay

Instructional Video: https://vitalconnect.com/docs/overlay-video.html

Note that looking in a mirror can be helpful in doing the following steps.

Step 1: Preparation

Image shows cleaning the skin area.

• For people with dense chest hair, it is advised to trim the chest hair before application of the VitalPatch and the adhesive overlay.
• Clean the skin around the VitalPatch device with an alcohol prep-pad. Avoid touching VitalPatch with the pad.
• Allow the skin to dry.

Step 2: Prepare Overlay

Image shows the adhesive overlay with a notched corner and a tab being bent upwards.

• Before applying the adhesive overlay, find the notched corner.
• Bend the tab up approximately half an inch to match the image. This creates a bent tab that will help you remove the white top liner later.

Step 3: Position Overlay

Image shows hands placing the adhesive overlay onto the VitalPatch device on the skin.

• Place the adhesive overlay over the VitalPatch such that the white liner is facing up away from the skin.
• Align the two cutouts of the adhesive overlay with the raised portions of the VitalPatch.

Step 4: Remove Blue Liner (First Side)

Image shows hands peeling off a blue liner from the adhesive overlay.

• Once the adhesive overlay is in position, with one hand hold one end of the adhesive overlay firmly in place.
• With the other hand find and grab onto the blue liner.
• Slowly peel away and remove the blue liner as shown in the image.
• Then press the adhesive overlay to adhere it to the skin and VitalPatch.

Step 5: Remove Blue Liner (Second Side)

Image shows hands peeling off the second blue liner from the adhesive overlay.

• Repeat Step 4 for the remaining blue liner.

Step 6: Press Down

Image shows hands pressing down on the applied adhesive overlay.

• Press down the adhesive overlay to adhere it to the skin and VitalPatch.

Step 7: Remove White Liner

Image shows hands peeling off the white top liner from the adhesive overlay.

• Peel off the top white liner starting with the bent tab.
• Press the overlay against the skin and VitalPatch with your other hand as you continue to remove the whole white liner.

Step 8: Seal Edges

Image shows hands pressing down on the edges of the adhesive overlay to seal it.

• Press down on the adhesive overlay to seal all the edges against the skin and VitalPatch.

Removal of the Adhesive Overlay and the VitalPatch

Step 1: Gentle Removal

Image shows hands gently pulling the adhesive overlay and VitalPatch off the skin.

• When removing the adhesive overlay and the VitalPatch:
  • Grasp a corner of the overlay and pull it off the skin by stretching it horizontally to help release it from the skin.
  • Continue peeling off the adhesive overlay and the VitalPatch.
• If the VitalPatch does not come off with the overlay, remove the VitalPatch by peeling it from one end.

Adverse Event Reporting

Adverse events and/or potential patient injury complications that are reasonably associated with the use of the VitalPatch Adhesive Overlay should be reported, as follows:

Contact Information