User's Guide

• Press the button on the device to verify that the device is working. The device light
should blink. If your device is not blinking, please see Troubleshooting & FAQs.
• Place the device on the flattest part of your left chest, two inches below the collar bone.
• If the device falls off due to sweat or moisture, dry off the adhesive and reapply. If the
device continues to fall off due to low adhesion, remove and replace the adhesive. Then,
reapply the device to the placement area.
• If mild irritation occurs, replace the adhesive to maintain comfort.
• To allow skin to breathe, place the device in a new location when replacing the adhesive.
• Wear a shirt while sleeping to keep the device secure.
Wear the device for the prescribed duration.
For help, email [e-mail]
For additional support, please email
[e-mail]
Wear Instructions
For Best Results:
Model: BIOST0208
FCC ID: 2ASE7- BIOST0208
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant
to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful
interference in a residential installation. This equipment generates uses and can radiate radio frequency
energy and, if not installed and used in accordance with the instructions, may cause harmful interference
to radio communications. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or television reception, which can
be determined by turning the equipment off and on, the user is encouraged to try to correct the
interference by one or more of the following measures:
•Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
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.
Changes or modifications not expressly approved by the party responsible for compliance could void the
user's authority to operate the equipment.
CAUTION: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
BioIntellisense and Biosticker are trademarks or registered trademarks of BioIntellisense, Inc.
Responsible Party:
BioIntellisense, Inc.
570 El Camino Real #200
Redwood City, CA 94063
Our full Notice of Privacy Practices and Terms of Service, found at www.biointellisense.com/legal,
describes our privacy practices, our legal duties, and your rights concerning your Protected Health
Information (PHI).
FCC Statement & Legal Notices
Heart Rate Range: 30-130 beats per minute (< ± 5
beats per minute).
Respiratory Rate Range: 10-30 breaths per minute
with a mean absolute error of < 3 breaths per minute.
4-42 breaths per minute with a mean absolute error of
< 1.5 breaths per minute.
Skin Temperature: Complies with ASTM E1112.
Can I shower with my device?
Yes, but showers should be short. We recommend showering with your back against the
water and keeping soaps and lotions away. While drying off, hold the BioSticker
TM
down
with one hand. Please do not apply any deodorant or lotion to the application area.
Can I swim or bathe with my device?
You should not submerge the device underwater. Baths should be fine as long as the
device is kept above water.
What activities should I avoid?
Avoid activities that cause excessive sweating. They can cause the BioSticker
TM
to become
loose and shorten wear time.
How long should I wear my device for?
Wear your device for the prescribed number of days. If you see moisture in the adhesive
or are experiencing mild irritation, replace the adhesives to maintain comfort.
I’m experiencing some skin irritation, what should I do?
If you are experiencing severe skin irritation, contact support immediately.
How do I know my device is working?
Press and release the button on the hexagon side of the device. The device light should
blink. If the device is not blinking, wait 2 minutes and try again.
Why is my device blinking blue?
Occasionally, the device will perform a system reboot. After the reboot is complete, the
light will blink blue.
My device isn’t blinking at all, what do I do?
The device may have shut down, automatically. To activate the device, press and hold the
button for 5 seconds. When you release the button, the light should blink blue.
Troubleshooting & FAQs
Symbol Library
FCC icon
Consult instructions
for use
Apply by date
Date of
manufacture
Model number
Lot number
Type BF
applied part
Temperature
limitation
Humidity
limitation
Keep dry
Latex-free
Don’t use if package
is damaged
R L
Trim body hair
Step 1: Prepare the skin
Identify the
placement area
• Upper left chest
• A couple inches below
LEFT collar bone
If necessary, remove
body hair from the
upper left chest with an
electric trimmer.
Clean the area
with warm water
Once the skin is free of
excess hair, wipe with a
warm, damp cloth.
L
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f
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1
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Step 2: Prepare the BioSticker
TM
Locate the
BioSticker
TM
and adhesives
Locate and remove
the BioSticker
TM
and
adhesives from
packaging.
Apply adhesive to
the BioSticker
TM
• Remove the adhesive
backings from one
side of the adhesive
• Attach it to black side
of the BioSticker
TM
Activate the
BioSticker
TM
Press and release the
power button. The light
should blink.
Press Here
x10
Step 3: Apply BioSticker
TM
to Left Chest
Remove adhesive
backings
Remove remaining
adhesive backings.
Apply pressure to
the device
Press down and apply
pressure to ensure good
contact with the skin.
Apply BioSticker
TM
to placement area
Apply the BioSticker
TM
to the flattest part of
your chest, 2” below
your collar bone.
Wipe
2”
L
Intended Use & Precautions
DO NOT wear device over excessive
body hair in the torso area. Excessive
body hair should be removed before
application.
DO NOT place on broken skin
including wounds, sores, or abrasions.
DO NOT continue wearing if severe
discomfort or irritation occurs.
DO NOT wear more than one
device at a time. Incorrect handling,
excessive force, or dropping the
device may cause malfunction or
permanent damage.
DO NOT excessively bend or twist
the BioSticker
TM
.
DO NOT wear or use the BioSticker
TM
during a magnetic resonance imaging
(MRI) procedure or in a location where
it will be exposed to strong
electromagnetic forces.
DO NOT modify or attempt to take
the device apart.
DO NOT submerge the device in
water. The device may be removed
for a bath or shower and then
re-applied afterwards.
Keep the device away from children
and pets. The BioSticker
TM
may be a
choking hazard and may be harmful
if swallowed.
Clinical validation has not been
performed on patients who are
pregnant, breastfeeding, and those
wearing a defibrillator or pacemaker.
This device is non-sterile.
The BioSticker
TM
is to be worn on
the chest.
Excessive sweat will reduce wear
time. The device may be removed
before exercise and then re-applied
afterwards.
This device contains parts and
assemblies susceptible to damage
by electrostatic discharge.
The BioSticker Platform is a wireless remote monitoring system intended for use by
healthcare professionals for continuous collection of physiological data in home and
healthcare settings while the patient is at rest. This can include heart rate, respiratory rate,
skin temperature, activity (including step count), and posture (body position relative to
gravity including fall). Data can be transmitted either wirelessly or via a wired connection
for storage and analysis.
The device is intended for use on general care patients who are 18 years of age or older
as a general patient monitor, to provide physiological information. The data from the
BioSticker Platform are intended for use by healthcare professionals as an aid to diagnosis
and treatment.
The device is not intended for use on critical care patients.
Refer to your physician’s instructions for wear time and return instructions.
Wear Instructions & User Guide
Manufactured by: BioIntelliSense, Inc. 570 El Camino Real #200, Redwood City, CA 94063
Product Name: BioSticker
Model Number: BIOST0208
Battery: 620mAh, Lithium Coin Cell
Operating Conditions:
Temperature Range: 10-40ºC
Humidity Range: 10-95% RH
Atmospheric Pressure: 70-102 kPa
Water Resistance: IPX8
Technical Specifications