User Guide

• When no longer sticky.
• If you experience minor irritation
or redness in placement area.
REPLACE YOUR ADHESIVE
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 dierent location within the
placement area.
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.
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.
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.
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 device’s button.
The device light will blink GREEN 4
TIMES. If your device light is blinking
a dierent color, please reference the
Button Press Light Patterns table on the
front page.
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.
• Heart Rate and Respiratory Rate
data is only reported when the
wearer is at rest and not reported
during periods of signicant motion
or activity.
TROUBLESHOOTING & FAQS
The device is a choking hazard and is
harmful if swallowed.
• REMOVE the BioButton Rechargeable
device prior to any debrillation
events. Clinical validation has not been
performed for persons who have a
debrillator, 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.
• 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.
WARNINGS & PRECAUTIONS
Manufactured by BioIntelliSense, Inc.
570 El Camino Real #200, Redwood City, CA 94063
JUNE 2022 IFU-BBR-1504 Ver. 2
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.
INDICATIONS FOR USE
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: [e-mail]
Call: 888.908.8804 (US ONLY)
Use QR code or visit:
BioIntelliSense.com
/support
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.
RECHARGE YOUR DEVICE