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BioButton
Rechargeable Instructions for Use
®
Table of Contents
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Indications for 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 patients 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.
IN CASE OF EMERGENCY, CALL 911 IMMEDIATELY
Our support line is not for medical emergencies. If you believe you have an emergency, call 911.
IFU-BBR-2022 Ver. 5 | October 2024
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Technical Specifications ..............................
Guidance and Declaration ..........................
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Summary of Contents for BioIntelliSense BioButton Rechargeable
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Page 1: Table Of Contents
BioButton Rechargeable Instructions for Use ® Table of Contents Indications for Use ...........1 Troubleshooting and FAQs ......7 Warnings and Precautions ......2 Safety and Regulatory Information .....8 Use Instructions ..........4 Technical Specifications ......During Monitoring Period ......7 Guidance and Declaration ......Indications for Use The BioButton®... -
Page 2: Warnings And Precautions
Warnings and Precautions DO NOT DO NOT wear device over excessive body hair. use accessories, detachable parts, and Excessive body hair should be trimmed using / or materials not described in the Instructions only an electric trimmer, before application. for Use. DO NOT WARNING: place on broken skin including wounds,... - Page 3 • • Keep the BioButton Rechargeable device away Press the device’s button regularly to check the from children and pets. The device is a choking indicator light and to verify that the device is in hazard and is harmful if swallowed.
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Page 4: Use Instructions
(Provided (Optional, Provided Separately) Separately) (Optional, Provided Separately) BioButton Rechargeable Device GET STARTED 5V 1A USB-A 1. PLUG the USB-A end of the charging cable into a POWER ADAPTER* 5V 1A USB-A power adapter*. 2. ATTACH the charging cable to the BioButton device (see image to the right). - Page 5 The light will blink BLUE 10 TIMES after the PRESS & device has powered on. (Note: the device may HOLD take up to 15 seconds to power on). LIGHT 5. ACTIVATE your BioButton Rechargeable device, following the instructions for either your BioMobile app or BioHub device. ®...
- Page 6 GET STARTED (CONTINUED) 9. TAKE one adhesive. Peel the backing from DEVICE SIDE of adhesive. 10. Place the BIOBUTTON RECHARGEABLE on the exposed adhesive. Turn the device over and remove remaining adhesive backing. 11. ADHERE the BioButton Rechargeable device to the upper left chest placement area near the sternum.
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Page 7: During Monitoring Period
When replacing the adhesive, you should apply the device to a different location within the placement area. OFFLOAD YOUR DATA Refer to your healthcare provider for more instructions on how to connect to the BioButton Rechargeable and view your data. -
Page 8: Safety And Regulatory Information
Union (ITU) Radio Regulations. Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment. BioIntelliSense and BioButton are trademarks or registered trademarks of BioIntelliSense, Inc. RESPONSIBLE PARTY: BioIntelliSense, Inc. -
Page 9: Symbol Library
TERMS OF USE STATEMENT Use of the BioIntelliSense Product(s) is subject to our: • Privacy Policy • Service Level and Support Terms • Website, Application, and Product User Terms of Use. You can find these policies at: biointellisense.com/legal 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. -
Page 10: Technical Specifications
Technical Specifications Product Name BioButton Rechargeable Model Number BIOST06040F, BIOST06040 Battery Lithium ion Operation Time Typically 7-30 days depending on mode Battery Lifetime 300 charging cycles Shelf Life 2 years. After 2 years, battery must be charged prior to use. -
Page 11: Guidance And Declaration
Guidance and Declaration — Electromagnetic Compatibility ELECTROMAGNETIC EMISSION The BioButton Rechargeable 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... - Page 12 ELECTROMAGNETIC IMMUNITY (CONTINUED) IMMUNITY IEC 60601 TEST COMPLIANCE ELECTROMAGNETIC TEST LEVEL LEVEL ENVIRONMENT - GUIDANCE Voltage Dips > Voltage Dips > Voltage dips, short Mains power quality should be that of a typical 95% reduction, 1 95% reduction, 1 interruptions and residential environment.
- Page 13 If the measured field strength in the location in which the BioButton Rechargeable is used exceeds the applicable RF compliance level above, the BioButton Rechargeable should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BioButton Rechargeable.
- Page 14 IMMUNITY TO RF WIRELESS COMMUNICATIONS EQUIPMENT TEST MAXIMUM IMMUNITY TEST BAND DISTANCE SERVICE SERVICE MODULATION FREQUENCY POWER LEVEL (MHZ) (V/M) (MHZ) Pulse modulation 380-390 TETRA 400 GMRS 460, 430-470 ± 5 kHz deviation FRS 460 1 kHz sine 710, 745, Pulse modulation 704 –...
- Page 15 RECOMMENDED SEPARATION DISTANCE BETWEEN PORTABLE AND MOBILE RF COMMUNICATIONS EQUIPMENT AND BIOBUTTON RECHARGEABLE The BioButton Rechargeable is intended for use in the electromagnetic environment in which radiated RF disturbances are controlled. The end user of the device can help prevent electromagnetic interference by...
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