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BioButton
Instructions for Use
TM
AUGUST 2020
Table of Contents
1
Indications for Use
2
2
3
4
Indications for Use
The BioButton
system is a remote patient
TM
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
IN CASE OF EMERGENCY, CALL 911 IMMEDIATELY
Our support line is not for medical emergencies. If you believe you have an emergency, call 911.
Version: BBN-LBL-IFU-FULL Rev. 0.5
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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.
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Related Manuals for BioIntelliSense BioButton BIOST03020
Summary of Contents for BioIntelliSense BioButton BIOST03020
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Page 1: Table Of Contents
BioButton Instructions for Use AUGUST 2020 Table of Contents Indications for Use Replace Your Adhesive BioButton Overview Troubleshooting and FAQs Package Contents Safety and Regulatory Information Warnings and Precautions Technical Specifications Use Instructions 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... -
Page 2: Biobutton Overview
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. 0.5... -
Page 3: Warnings And Precautions
Warnings and Precautions DO NOT DO NOT wear device over excessive body hair. continue wearing if severe discomfort or Excessive body hair should be trimmed using irritation occurs. only an electric trimmer, before application. DO NOT exert excessive force, drop, modify, or DO NOT place on broken skin including wounds, attempt to take apart the device. -
Page 4: Use Instructions
Use Instructions BEFORE YOU START a. Download and install the BioMobile app for iOS or Android phones. We support iOS 13+ and Android 9+ b. Set up BioHub unit by following the instructions in the BioHub box. DO NOT proceed until BioMobile app or BioHub is set up. GET STARTED 1. -
Page 5: Replace Your Adhesive
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
This device complies with FCC Radiation Exposure limits set forth for an uncontrolled environment. This device should be installed and operated with a minimum distance of 20 cm between the radiator and your body. BioIntelliSense and BioButton are trademarks or registered trademarks of BioIntelliSense, Inc. RESPONSIBLE PARTY: BioIntelliSense, Inc. - 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. 0.5...
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Page 8: Technical Specifications
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 <... -
Page 9: Guidance And Declaration
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 COMPLIANCE ELECTROMAGNETIC ENVIRONMENT &... - 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 D = 2.3 √P 0.01 0.12 0.23 0.38 0.73 Contact Us For non-urgent support or questions about our product, please call 888.908.8804 or email support@biointellisense.com MANUFACTURED BY BioIntelliSense, Inc. 570 El Camino Real #200 Redwood City, CA 94063 Version: BBN-LBL-IFU-FULL Rev. 0.5...
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