BioIntelliSenseBioIntelliSense
Instruction Manual for BioIntelliSense models including: BIOST03020, 2ASE7-BIOST03020, 2ASE7BIOST03020, BioButton Medical Grade Device, BIOST03020 BioButton Medical Grade Device
BioIntelliSense, Inc. BIOST03020 BioButton-C 2ASE7-BIOST03020 2ASE7BIOST03020 biost03020
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DocumentDocumentBioButtonTM Instructions for Use AUGUST 2020 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 Indications for Use The BioButtonTM 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. 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 1 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 2 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 morethan 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. Version: BBN-LBL-IFU-FULL Rev. 0.5 3 Use Instructions BEFORE YOU START a. Download and install the BioMobileTM app for iOS or Android phones. We support iOS 13+ and Android 9+ b. Set up BioHubTM unit by following the instructions in the BioHub box. 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. TRIM ANY BODY 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 remaining adhesive backing. 6. ADHERE BioBioButton to chest. Apply pressure for 15 seconds You're done! LIGHT PATTERN MEANINGS Press the BioButton's button and confirm the light blinks 5 times. LIGHTS 4 regular blinks MEANING Actively monitoring 5 rapid blinks 10 rapid blinks (repeated 4 times) Worn for maximum wear time (up to 90 days) Not monitoring, connect to BioMobile app or BioHub to restart monitoring Solid light or no light Error detected, contact support immediately Version: BBN-LBL-IFU-FULL Rev. 0.5 4 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. 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 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. Version: BBN-LBL-IFU-FULL Rev. 0.5 5 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 www.biointellisense.com/website-and-product-user-terms-of-use · Website Privacy Policy at www.biointellisense.com/website-privacy-policy · Product and Data-as-a-Service Privacy Policy at www.biointellisense.com/product-and-service-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, sneezing and vomit frequency and other symptomatic or biometric data. The Product(s) may also be configured to track and record proximity and duration data in relation to other Product(s). 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. Version: BBN-LBL-IFU-FULL Rev. 0.5 6 SYMBOL LIBRARY MRI unsafe Don't use if package is damaged Latex-free Consult with instructions for use Type BF applied part FCC icon Single-use only Temperature limitation Humidity limitation Apply by date Lot number Model number Warning Version: BBN-LBL-IFU-FULL Rev. 0.5 7 Technical Specifications Product Name Model Number Battery Heart Rate* Range Respiratory Rate* Range Skin Temperature Range Skin Temperature Accuracy Ambient Temperature STORAGE CONDITIONS Temperature Range Humidity Range OPERATING CONDITIONS Temperature Range Humidity Range Atmospheric Pressure Water Resistance COMMUNICATIONS Communication Technology Distance Radio Modulation GFSK Radio Frequency Transmit Power Security BioButton BIOST03020 140mAh, CR1632 40 to 125 beats per minute (<± 5 beats per minute) 10 to 30 breaths per minute 86°F to 107.6°F (30°C - 42°C) < 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 ± 0.3°C) 50°F to 110°F ± 1°F (10°C to 43°C) -4°F to 122°F (-20°C to 50°C) 0 - 95% RH 32°F to 122°F (0°C to 50°C) 0 - 95% RH 70 - 102 kPa IP47 Bluetooth (BT4.2) Max. 10 meters (30 feet) line of sight Guassian frequency shift keying 2.4 2.5 GHz 0dBm AES-CTR 128 bit encryption (Advanced encryption standard counter mode) * Measurements are taken at rest Version: BBN-LBL-IFU-FULL Rev. 0.5 8 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 Electrostatic discharge (ESD) IEC 61000-4-2 Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 IEC 60601 TEST LEVEL ± 8 kV contact ± 15 kV air 30 A/m COMPLIANCE LEVEL ± 8 kV contact ± 15 kV air 30 A/m ELECTROMAGNETIC ENVIRONMENT - GUIDANCE 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 magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz 10 V/m 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 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: Version: BBN-LBL-IFU-FULL Rev. 0.5 9 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) SERVICEA MODULATIONB MAXIMUM DISTANCE IMMUNITY TEST POWER (W) (M) LEVEL (V/M) 385 380-390 TETRA 400 Pulse modulationb 18 Hz 1.8 0.3 27 450 430-470 GMRS 460, FRS 460 FMc ± 5 kHz deviation 1 kHz sine 2 0.3 28 710, 745, 780 704 787 LTE Band 13, 7 Pulse modulationb 217 Hz 0.2 0.3 9 GSM 800/900, 810, 870, 930 800 960 TETRA 800, iDEN 820, CDMA 850, Pulse modulationb 18 Hz 2 0.3 28 LTE Band 5 GSM 1800; CDMA 1900; 1720, 1845, 1970 1700 1990 GSM 1900; DECT; Pulse modulationb 217 Hz 2 0.3 28 LTE Band 1, 3, 4, 25; UMTS Bluetooth, WLAN, Pulse 2450 24002570 802.11 b/g/n, RFID modulationb 2 0.3 28 2450, LTE Band 7a 217 Hz 5240, 5500, 5785 5100 5800 WLAN 802.11 a/n Pulse modulationb 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 worst case. Version: BBN-LBL-IFU-FULL Rev. 0.5 10 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. RATED MAXIMUM OUTPUT POWER OF TRANSMITTER (W) 0.01 0.1 1 10 100 SEPARATION DISTANCE ACCORDING TO FREQUENCY OF TRANSMITTER (M) 80 MHZ TO 800 MHZ D = 1.2 P 0.12 0.38 1.2 3.8 12 800 MHZ TO 2.7 GHZ D = 2.3 P 0.23 0.73 2.3 7.3 23 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 11