GET STARTED 1 CHARGE the BioButton device by ALIGNING and ATTACHING the charging cable to the device. Proceed when the indicator light turns SOLID GREEN, indicating a full charge. 3 ACTIVATE your BioButton Rechargeable device with the designated APP or HUB DEVICE indicated in your programs instructions. 5 Locate placement area on UPPER LEFT CHEST, two inches below collar bone. 7 TAKE one adhesive. Peel the backing from DEVICE SIDE of adhesive. INSTRUCTIONS FOR USE For complete instructions, visit:
BioIntelliSense.com/support DEVICE + COMPONENTS OVERVIEW Button Charging contacts Indicator light FULLY INSERT 2 PRESS AND HOLD the button for 2 SECONDS. The light will blink BLUE 10 TIMES after the device has powered on. (Note:
the device may take up to 15 seconds to power on) A P P or HUB Note: Device may perform a rmware update before activation. If so, the light will slowly blink blue for a few minutes. the light does not blink, refer to the Button Light Pattern guide after step 10 for guidance. PRESS &
HOLD LIGHT CHARGING CABLE ADHESIVES NO RAZORS NO WAXING NO ALCOHOL 9 ADHERE the BioButton Rechargeable device to the upper left chest placement area. Apply pressure for 15 SECONDS. N PATTERN MEANING 10 blue blinks Not Activated Continuous slow blue blinking 4 green blinks Updating Firmware Actively Monitoring 5 orange blinks Low Battery Solid red light or no light Error detected, contact support 4 CONFIRM BIOBUTTON ACTIVATION by pressing the button and verifying that the light blinks GREEN 4 TIMES. 6 TRIM ANY BODY HAIR using only an electric trimmer and CLEANSE AREA with a warm, damp cloth. 8 Place the BIOBUTTON on the exposed adhesive. Turn the device over and remove remaining adhesive backing. 10 Press the button to check the device status. Refer to the Button Light Pattern guide below. PRESSDOW REPLACE YOUR ADHESIVE SUPPORT TROUBLESHOOTING & FAQS INTENDED USE When no longer sticky. If you experience minor irritation or redness in placement area. In the event of a medical emergency, contact your medical emergency service. For additional support including tips on long-term wear and adhesive information:
Visit: BioIntelliSense.com/support Email: support@biointellisense.com Call: 888.908.8804 (US ONLY) Can I shower or exercise with the device? Yes, the BioButton device 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. Im experiencing some skin irritation, what should I do? Minor skin irritation and itching may occur while wearing the device. If a severe reaction develops (i.e. hives or blisters), discontinue wearing and contact your physician. Can I swim or bathe with the device? Yes, the BioButton device 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. How long should I wear my BioButton device? Please wear your BioButton device for the entire monitoring period. Each adhesive is designed for longer wear duration, typically up to 7 days, before replacing. For additional adhesive tips, visit BioIntelliSense.com/support. How do I know my device is working?
Press and release the devices button. The device light will blink GREEN 4 TIMES. If color, please reference the Button Press Light Patterns table on the front page. Ive tried powering on the device several times, and the light still wont blink blue. What do I do? Contact Customer Support immediately. You may be instructed to return the device and may receive a replacement kit if more data is needed for the monitoring period. REMOVE adhesive from bottom of device. Follow steps 5 - 9 to put on a new adhesive and reapply the device. RECHARGE YOUR DEVICE WARNINGS & PRECAUTIONS Check your BioButton's status daily by pressing the button. 5 ORANGE BLINKS indicates you should recharge it until the light pattern shown while charging is SOLID GREEN. LIGHT PATTERNS WHILE CHARGING PATTERN CHARGE LEVEL Blink orange 0% - 10%
Blink yellow 11% - 70%
Blink green 71% - 99%
Solid green 100%
DO NOT wear device over excessive body hair. Excessive body hair should be trimmed using only an electric trimmer, before application. DO NOT exert excessive force, drop, modify, or attempt to take apart the device. Doing so may cause malfunction or permanent damage. DO NOT place on broken skin including DO NOT wear or use the BioButton wounds, sores, or abrasions. DO NOT submerge the BioButton 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. device during a magnetic resonance imaging (MRI) procedure or in a location where it will be exposed to strong electromagnetic forces. Keep the BioButton Rechargeable device away from children and pets. The device is a choking hazard and is harmful if swallowed. REMOVE the BioButton Rechargeable device prior to any debrillation events. Clinical validation has not been performed for persons who have a debrillator, pacemaker device, and other implantable devices. Press the devices button regularly to check the indicator light and to verify that the device is in active monitoring mode. Heart Rate and Respiratory Rate data is collected at rest and not reported during periods of signicant motion or activity. Manufactured by BioIntelliSense, Inc. 570 El Camino Real #200, Redwood City, CA 94063 When replacing the adhesive, it is location within the placement area. The BioButton Rechargeable is a remote monitoring wearable device intended to collect physiological data which can include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data. The device is intended for use on users who are 18 years of age or older. The device does not output heart rate or respiratory rate measurements during periods of motion or activity. The device is not intended for use on critical care patients. NOTICE: Use of the BioIntelliSense Product(s) is subject to our Website and Product User Terms of Use at (BioIntelliSense.com/website-and-product-
user-terms-of-use), Website Privacy Policy at
(BioIntelliSense.com/website-privacy-policy), and Product and Data-as-a-Service Privacy Policy at (BioIntelliSense.com/product-and-service-
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, sneezing and vomit frequency and other symptomatic or biometric track and record proximity and duration data in relation to other Product(s). You understand that the Product(s) do not render medical advice or 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. 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, and (2) this device must accept any interference received, including interference that may cause undesired operation. OCTOBER 2021 BBNR-LBL-DWG-IFU Rev.0