BioIntelliSense BioButton COVID-19 Vaccine and Illness Prevention Instructions

BioButton COVID-19 Vaccine and Illness Prevention

Instructions for Use
For complete instructions, visit: BioIntelliSense.com/support

For additional support, please call
888.908.8804
or email [email protected]

In the event of a medical emergency, dial 911 immediately.

INTRODUCTION

INTENDED USE

The BioButton® System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.

• Data are securely transmitted via wireless connection from the device for storage, review, and further analysis.
• The data from the device are intended as an aid to diagnosis, diseases management, and treatment.
• The device is intended for use on users who are 18 years of age or older.
• The device is indicated for both prescription use as well as over-the-counter use (OTC).
• The device is not intended to output physiological measurements while the user undergoes significant motion or is active.
• The device is not intended for critical care.

NOTICE: Use of the BioIntelliSense Product(s) is subject to our Website and Product User Terms of Use (BioIntelliSense.com/legal/website-andproduct- user-terms-of-use) and our Website and Product Privacy Policy (BioIntelliSense.com/legal/privacy-policy) By using the Product(s), you indicate you have read these terms and policies and that you agree to them, including the limitations and disclaimers of liability. In particular, you understand and consent that use of the Product(s) measures and records personal information about you, including vital sign and other physiologic measurements. That information may include respiratory rate, heart rate, temperature, activity level, sleep duration, body position, step count, gait analysis, coughing, and other symptomatic or biometric data. You understand that the Product(s) do not render medical advice or diagnose or prevent any specific disease, including any communicable disease or virus. If you have any concerns about your health, including whether you have been exposed to or have contracted any disease or virus, immediately contact your healthcare provider.

GET STARTED

STEP 1
Press and hold the BioButton™ button for 2 SECONDS. Proceed when the LIGHT blinks repeatedly.

STEP 2
Locate area on UPPER LEFT CHEST, two inches below collar bone.

STEP 3
TRIM ANY BODY HAIR using only an electric trimmer and CLEANSE AREA with a warm, damp cloth.

STEP 4
Find adhesive. Peel the backing from DEVICE SIDE of adhesive.

STEP 5
Place the BioButton ON the exposed adhesive. Turn over and remove remaining adhesive backing.

STEP 6
Adhere BioButton to chest. Apply pressure for 15 SECONDS.

REPLACE YOUR ADHESIVE

• When no longer sticky.
• If you experience minor irritation or redness in placement area.

REMOVE adhesive from bottom of device. Follow steps 4 thru 6 to put on a new adhesive and reapply BioButton.

When replacing the adhesive, it is advised to apply the device in a different location within the placement area.

VERIFY DEVICE IS WORKING

Press the BioButton’s button and confirm the light blinks 4 TIMES. If the device blinks more than 4 times or does not blink at all, please contact support.

TROUBLESHOOTING & FAQS

• Can I shower or exercise with the BioButton? Yes, the BioButton is water resistant and can be worn during showers and exercise. Do not apply any deodorant or lotion to the placement areas as it will reduce adhesion of the device to the skin.
• Can I swim or bathe with the BioButton? Yes, the BioButton is water resistant and will continue working as long as it is not submerged more than 3 feet or kept underwater for longer than 30 minutes at a time. Prolonged exposure to water may cause the device to loosen from the skin.
• I’m experiencing some skin irritation, what should I do? Minor skin irritation and itching may occur while wearing the BioButton. If a severe reaction develops (i.e. hives or blisters), discontinue wearing and immediately contact your physician.
• How long should I wear my device? Please wear your device for the entire monitoring period, but no longer than 90 days. Each adhesive may be worn for up to 7 continuous days. You may replace the adhesive more often, as needed, to ensure good contact is maintained with the skin.
• How do I know my device is working? Press and release BioButton’s button. The device light will blink 4 times. If the device does not blink or blinks more than 4 times, please immediately contact Customer Support
• I’ve tried activating the device several times, and the light still won’t blink. What do I do? Contact Customer Support immediately (see front cover). You may be instructed to return the device and may receive a replacement kit if more data is needed for the monitoring period.

SUPPORT

For tips on long-term wear and additional adhesive support, visit: BioIntelliSense.com/support
If additional support is required, please call 888.908.8804
or email [email protected]

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference
2. This device must accept any interference received, including interference that may cause undesired operation

Manufactured by BioIntelliSense, Inc.
570 El Camino Real #200, Redwood City, CA 94063

WARNINGS & PRECAUTIONS

• DO NOT wear device over excessive body hair. Excessive body hair should be trimmed using only an electric trimmer, before application.
• DO NOT place on broken skin including wounds, sores, or abrasions.
• DO NOT submerge the device in more than 3 feet of water or submerge for longer than 30 minutes at a time. Prolonged exposure to water may cause the device to loosen from the skin.
• DO NOT continue wearing if severe discomfort or irritation occurs.
• DO NOT exert excessive force, drop, modify, or attempt to take apart the device. Doing so may cause malfunction or permanent damage.
• DO NOT wear or use the BioButton during a magnetic resonance imaging (MRI) procedure or in a location where it will be exposed to strong electromagnetic forces.
• Remove the BioButton prior to any defibrillation events. Clinical validation has not been performed for persons who have a defibrillator or pacemaker device.
• Keep the device away from children and pets. The BioButton device may be a choking hazard and may be harmful if swallowed.
• Press the BioButton’s button regularly to verify that it is working.

For additional support, please call
888.908.8804
or email [email protected]

In the event of a medical emergency, dial 911 immediately

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