Use Instructions

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Version: BBN-LBL-IFU-FULL Rev. 0.5 1

BioButton

Instructions for Use

AUGUST 2020

Indications for Use

The BioButton

system is a remote patient

monitoring system that is capable of, through a

wearable sensor device, continuously obtaining

physiological data from patients in both healthcare

settings and in-home settings for up to 90 days.

The physiological data collected by the

BioButton can include:

• Heart rate at rest

• Respiratory rate at rest

• Skin temperature

There are other non-medical data

to be collected and reported by the

device, including:

• Activity Level

• Body position

• Sleep Tracking

• Contact Tracing

The device is capable of remote transferring of

obtained physiological data from the patient’s

location to clinicians patients for storage,

analysis, and review.

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 BioButton System is intended

for use by healthcare professionals as an aid to

diagnosis and treatment.

The device is not intended for use on critical

care patients.

Table of Contents

1 Indications for Use

2 BioButton Overview

2 Package Contents

3 Warnings and Precautions

4 Use Instructions

5 Replace Your Adhesive

5 Troubleshooting and FAQs

6 Safety and Regulatory Information

8 Technical Speciﬁcations

9 Guidance and Declaration

IN CASE OF EMERGENCY, CALL 911 IMMEDIATELY

Our support line is not for medical emergencies. If you believe you have an emergency, call 911.

Summary of content (11 pages)

PAGE 1
BioButton Instructions for Use TM AUGUST 2020 Table of Contents 1 Indications for Use 5 Replace Your Adhesive 2 BioButton Overview 5 Troubleshooting and FAQs 2 Package Contents 6 Safety and Regulatory Information 3 Warnings and Precautions 8 Technical Specifications 4 Use Instructions 9 Guidance and Declaration Indications for Use The BioButton system is a remote patient monitoring system that is capable of, through a wearable sensor device, continuously obtaining physiological data fr
PAGE 2
BioButton Overview The BioButton wearable device is made of medical grade silicone and is adhered with a double-sided fabric adhesive. Package Contents • BioButton Device • Fabric Skirt Adhesives • Instructions for Use Version: BBN-LBL-IFU-FULL Rev. 0.
PAGE 3
Warnings and Precautions DO NOT wear device over excessive body hair. Excessive body hair should be trimmed using only an electric trimmer, before application. DO NOT continue wearing if severe discomfort or irritation occurs. DO NOT place on broken skin including wounds, sores, or abrasions. DO NOT exert excessive force, drop, modify, or attempt to take apart the device. Doing so may cause malfunction or permanent damage.
PAGE 4
Use Instructions BEFORE YOU START a. Download and install the BioMobile app for iOS or Android phones. We support iOS 13+ and Android 9+ TM b. Set up BioHub unit by following the instructions in the BioHub box. TM DO NOT proceed until BioMobile app or BioHub is set up. GET STARTED 1. Press and hold the button for 2 SECONDS. Proceed when the LIGHT blinks repeatedly. 2. Locate area on UPPER LEFT CHEST, two inches below collar bone. 3.
PAGE 5
Replace Your Adhesive • When no longer sticky. • If you experience redness or irritation in the placement area. REMOVE adhesive from bottom of device. Follow steps 4 through 6 to put on a new adhesive and reapply BioButton. When replacing the adhesive, it is advised to apply the device to a different location within the placement area. Troubleshooting and FAQs Can I shower or exercise with my device? Yes, the BioButton is water resistant and can be worn during showers and exercise.
PAGE 6
Safety and Regulatory Information FCC STATEMENT Model: BIOST03020 FCC ID: 2ASE7- BIOST03020 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.
PAGE 7
SYMBOL LIBRARY MRI unsafe Temperature limitation Don’t use if package is damaged Humidity limitation Latex-free Apply by date Consult with instructions for use Lot number Type BF applied part Model number FCC icon Warning Single-use only Version: BBN-LBL-IFU-FULL Rev. 0.
PAGE 8
Technical Specifications Product Name BioButton Model Number BIOST03020 Battery 140mAh, CR1632 Heart Rate* Range 40 to 125 beats per minute (<± 5 beats per minute) Respiratory Rate Range 10 to 30 breaths per minute Skin Temperature Range 86°F to 107.6°F (30°C - 42°C) Skin Temperature Accuracy < 96.4°F ± 0.5°F (< 35.8°C ± 0.3°C) 96.4°F to 98°F ± 0.3°F (35.8°C to 37°C ± 0.2°C) 98°F to 102°F ± 0.2°F (37°C to 39°C ± 0.1 °C) 102°F to 106°F ± 0.3°F (39°C to 41°C ± 0.2°C) > 106°F ± 0.5°F (> 41°C ± 0.
PAGE 9
Guidance and Declaration — Electromagnetic Compatibility ELECTROMAGNETIC EMISSION The BioButton sensor is intended for use in the electromagnetic environment specified below. The user of the device shall ensure that the device is used in such an environment. EMISSION TEST METHOD RF emissions CISPR 11: 2009 + AI:2010 RF emissions CISPR 11: 2009 + AI:2010 COMPLIANCE LEVEL ELECTROMAGNETIC ENVIRONMENT & GUIDANCE The BioButton sensor uses RF energy only for its internal function.
PAGE 10
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. (a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
PAGE 11
RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND BIOBUTTON The BioButton is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled.