BioIntelliSense BioButton Supplemental Vaccine Instructions

BioButton® Instructions for Use
SEPTEMBER 2021

Indications for Use

The BioButton® System is a remote monitoring wearable device intended for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This could include heart rate, respiratory rate, skin temperature, and other symptomatic or biometric data.
Data are securely transmitted via wireless connection from the device for storage, review, and further analysis.
The data from the device are intended as an aid to diagnosis, diseases management, and treatment.

The device is intended for use on users who are 18 years of age or older.
The device is indicated for both prescription use as well as over-the-counter use (OTC).
The device is not intended to output physiological measurements while the user undergoes significant motion or is active.
The device is not intended for critical care.

IN CASE OF EMERGENCY, CALL 911 IMMEDIATELY
Our support line is not for medical emergencies. If you believe you have an emergency, call 911.

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 place on broken skin including wounds, sores, or abrasions.
DO NOT submerge the 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 during a magnetic resonance imaging (MRI) procedure or in a location where it will be exposed to strong electromagnetic forces.

• Remove the BioButton prior to any defibrillation events. Clinical validation has not been performed for persons who have a defibrillator or pacemaker device.
• Keep the device away from children and pets. The BioButton device may be a choking hazard and may be harmful if swallowed.
• Press the BioButton’s button regularly to verify that it is working.

Use Instructions

GET STARTED

1. Press and hold the button for 2 SECONDS. Proceed when the LIGHT blinks repeatedly.
2. Locate the area on UPPER LEFT CHEST, two inches below the collar bone.
3. TRIM ANYBODY HAIR using only an electric trimmer and CLEANSE AREA with a warm, damp cloth.
4. Find adhesive. Peel backing from DEVICE SIDE of adhesive.
5. Place the BioButton ON the exposed adhesive. Turn over and REMOVE the remaining adhesive backing.
6. ADHERE BioButton to the chest. Apply pressure for 15 seconds.
   You’re done!

LIGHT PATTERN MEANINGS
Press the BioButton’s button and confirm the light blinks 4 times.

6 slow blinks, alternating green and yellow (for older devices: 5 fast green blinks)| Worn for maximum wear time (up to 60 days)
2 regular blinks| Successful system boot up
10 rapid blinks (repeated 7 times)| Not monitoring. Connect to mobile app, BioSync app, or BioHub to restart monitoring
25 rapid blinks| Failed system boot-up, contact support immediately

Replace Your Adhesive

• When no longer sticky.
• If you experience redness or irritation in the placement area.

REMOVE adhesive from the bottom of the 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. 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 BioButton?
Yes, the BioButton 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 BioButton. If a severe reaction develops (i.e. hives or blisters), discontinue wearing and immediately contact your physician.
How long should I wear my device?
Please wear your device for the entire monitoring period, but no longer than 90 days. Each adhesive may be worn for up to 7 continuous days. You may replace the adhesive more often, as needed, to ensure good contact is maintained with the skin.
How do I know my device is working?
Press and release BioButton’s button. The device light will blink 4 times. If the device does not blink or blinks more than 4 times, please immediately contact Customer Support  (see front cover).
I’ve tried activating the device several times, and the light still won’t blink. What do I do?
Contact Customer Support immediately (see front cover). You may be instructed to return the device and may receive a replacement kit if more data is needed for the monitoring period.

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. 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.
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.
570 El Camino Real #200
Redwood City, CA 94063

TERMS OF USE STATEMENT
NOTICE: Use of the BioIntelliSense Product(s) is subject to our

• Website and Product User Terms of Use at BioIntelliSense.com/legal/website-and-product-user-terms-of-use
• Website and Product Privacy Policy at BioIntelliSense.com/legal/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, and other symptomatic or biometric data. 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.

SYMBOL LIBRARY

| MRI unsafe| | Temperature limitation
---|---|---|---
| MRI unsafe| | 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| |

Technical Specifications

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 ± 0.3°C)
Ambient Temperature|  50°F to 110°F ± 1°F (10°C to 43°C)
STORAGE CONDITIONS
Temperature Range|  -4°F to 104°F (-20°C to 40°C)
Humidity Range| 10 – 95% RH
OPERATING CONDITIONS
Temperature Range| 32°F to 104°F (0°C to 40°C)
Humidity Range| 10 – 95% RH
Atmospheric Pressure| 70 – 102 kPa
Water Resistance|  IP47
COMMUNICATIONS
Communication Technology| Bluetooth (BT4.2)
Distance| Max. 10 meters (30 feet) line of sight
Radio Modulation GFSK| Gaussian frequency-shift keying
Radio Frequency| 2.4 – 2.5 GHz
Transmit Power|  0dBm
Security| AES-CTR 128 bit encryption (Advanced encryption standard counter mode)

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| COMPLIANCE
LEVEL| ELECTROMAGNETIC ENVIRONMENT & GUIDANCE
---|---|---
RF emissions CISPR 11: 2009 +  AI:2010| GROUP 1| The BioButton sensor uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
RF emissions CISPR 11: 2009 +  AI:2010| CLASS B| The BioButton sensor is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

ELECTROMAGNETIC IMMUNITY
The BioButton sensor is intended for use in the electromagnetic environment specified below. The end-user of the device should assure that it is used in such an environment.

IMMUNITY TEST| IEC 60601
TEST LEVEL| COMPLIANCE
LEVEL| ELECTROMAGNETIC ENVIRONMENT – GUIDANCE
---|---|---|---
Electrostatic
discharge (ESD) IEC
61000-4-2| ± 8 kV contact
± 15 kV air| ± 8 kV contact
± 15 kV air| Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30 %.
Power frequency
(50/60 Hz) magnetic
field IEC 61000-4-8| 30 A/m| 30 A/m| Power frequency magnetic fields should be at levels characteristic of a typical location in a  typical commercial or hospital environment.
| | | Portable and mobile RF communications equipment should be used no closer to any part  of the BioButton sensor than recommended to the frequency of the transmitter.
Recommended separation distance:
d = 1.2 √P 80 MHz to 800 MHz
d = 2.3 √P 800 MHz to 2.7 GHz
Radiated RF IEC
61000-4-3| 10 V/m
80 MHz to 2.7
GHz| 10 V/m| where P is the maximum output power rating of the transmitter in watts (W)  according to the transmitter manufacturer and d is the recommended separation distance in meters (m).
| | | Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey(a) should be less than the compliance level in each frequency range(b).
Interference may occur in the vicinity of equipment marked with the following symbol:

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. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the BioButton is used exceeds the applicable RF compliance level above, the BioButton should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the BioButton.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

IMMUNITY TO RF WIRELESS COMMUNICATIONS EQUIPMENT

TEST
FREQUENCY
(MHZ)

| BANDA
(MHZ)| SERVICE a| MODULATIONʙ| MAXIMUM
POWER (W)| DISTANCE
(M)|

IMMUNITY TEST
LEVEL (V/M)

---|---|---|---|---|---|---
385| 380-390| TETRA 400| Pulse modulation 18| 2.| 0.3| 27
450| 430-470| GMRS 460,
FRS 460,| FMC s5 kHz deviation 1 kHz  sine| 2| 0.3| 28
710,
745,
780| 704 – 787| LTE Band 13| Pulse modulation
217 Hz| 0.2| 0.3| 9
810, 870,
930| 800 – 960| GSM 800/900,
TETRA 800,
iDEN 820,
CDMA 850,
LTE Band 5| Pulse modulationb 18 Hz| 2| 0.3| 28
1720, 1845,
1970| 1700 – 1990| GSM 1800;
CDMA 1900;
GSM 1900;
DECT;
LTE Band 1, 3, 4,
25; UMTS| Pulse modulationb 217 Hz| 2| 0.3| 28

2450

| 2400-2570| Bluetooth, WLAN,
80211 b/g/n, RFID
2450, LTE Band 7°| Pulse modulation 217 Hz| 2| 0.3| 28
5240, 5500,
5785| 5100 -5800| WLAN 802.11 a/n| Pulse modulation 217 Hz| 0.2| 0.3| 9

a For some services, only the uplink frequencies are included.
b The carrier shall be modulated using a 50 % duty cycle square wave signal.
c As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because while it does not represent actual modulation, it would be the worst case.

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. The end-user of the device can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the BioButton sensor as recommended below, according to the maximum output power of the communications equipment.

| SEPARATION DISTANCE ACCORDING TO FREQUENCY OF
TRANSMITTER (M)
---|---
RATED MAXIMUM OUTPUT
POWER OF TRANSMITTER
(W)| 80 MHZ TO 800 MHZ
D = 1.2 √P| 800 MHZ TO 2.7 GHZ
D = 2.3 √P
0.01| 0.12| 0.23
0.1| 0.38| 0.73
1| 1.2| 2.3
10| 3.8| 7.3
100| 12| 23

Contact Us
For non-urgent support or questions about our product, please call 888.908.8804 or email [email protected]

MANUFACTURED BY
BioIntelliSense, Inc.
570 El Camino Real #200
Redwood City, CA 94063
Version: BBN-LBL-IFU-FULL Rev. 2.0

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