BBN-R V2 BioButton Temperature and Vital Signs Monitoring Device User Guide

BBN-R V2 BioButton Temperature and Vital Signs Monitoring Device

DEVICE + COMPONENTS OVERVIEW

GET STARTED

1. CHARGE the BioButton device with provided charging cable (see below to correctly attach). The indicator light will BLINK when device is charging.

2. Proceed when the indicator light turns SOLID GREEN, indicating a full charge.
   PATTERN| CHARGE LEVEL
   ---|---
   Blink orange| 0% – 10%
   Blink yellow| 11% – 70%
   Blink green| 71% – 99%
   Solid green| 100%

3. DISCONNECT charging cable and PRESS the button. 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)

4. ACTIVATE your BioButton Rechargeable device with the designated APP or HUB DEVICE indicated in your program’s instructions.
   Note: Device may perform a firmware update before activation. If so, the light will slowly blink blue for a few minutes.

5. CONFIRM BIOBUTTON
   ACTIVATION by pressing the button and verifying that the light blinks GREEN 4 TIMES. If the blink pattern is different or the light does not blink, refer to the Button Light Pattern guide after step 11 for guidance.

6. Locate placement area on UPPER LEFT CHEST, two inches below collar bone, and close to the sternum.

7. CLEANSE AREA with a warm, damp cloth. Note: TRIM ANY BODY HAIR using only an electric trimmer.

8. TAKE one adhesive. Peel the backing from DEVICE SIDE of adhesive.

9. Place the BIOBUTTON on the exposed adhesive. Turn the device over and remove remaining adhesive backing.

10. ADHERE the BioButton Rechargeable device to the upper left chest placement area near the sternum. Apply pressure for 15 SECONDS.

11. Press the button to check the device status. See Button Light Pattern guide below.
    PATTERN| MEANING
    ---|---
    10 blue blinks| Not Activated
    Continuous slow blue blinking| Updating Firmware
    4 green blinks| Actively Monitoring
    5 orange blinks| Low Battery
    Solid red light

or no light

| Error detected,

contact support

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 6 – 10 to put on a new adhesive and reapply the device.

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

RECHARGE YOUR DEVICE

Check your BioButton’s status daily by pressing the button.
5 ORANGE BLINKS indicates a low battery. Please charge your BioButton until the light is SOLID GREEN.

SUPPORT

In the event of a medical emergency, contact your medical emergency service.
For additional support
including tips on long-term wear and adhesive information:
Email: support@biointellisense.com Call: 888.908.8804 (US ONLY)

TROUBLESHOOTING & FAQS

1. 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.

2. 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.

3. I’m 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.

4. 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.

5. How do I know my device is working? Press and release the device’s button. The device light will blink GREEN 4 TIMES. If your device light is blinking
   a different color, please reference the Button Press Light Patterns table on the front page.

6. I’ve tried powering on the device several times, and the light still won’t 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.

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 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.
• 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 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 defibrillation events. Clinical validation has not been performed for persons who have a defibrillator, pacemaker device, and other implantable devices.
• Press the device’s 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 only reported when the wearer is at rest and not reported during periods of significant motion or activity.

INDICATIONS F OR USE

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 data. The Product(s) may also be configured to 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 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.
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.

References

• BioIntelliSense
• BioIntelliSense

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