FCC ID: 2ASE7-BIOST0208 BioSticker

Intended Use & Precautions The BioSticker Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings while the patient is at rest. This can include heart rate, respiratory rate, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data can be transmitted either wirelessly or via a wired connection for storage and analysis. 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 BioSticker Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients. DO NOT wear device over excessive body hair in the torso area. Excessive body hair should be removed before application. DO NOT place on broken skin including wounds, sores, or abrasions. DO NOT continue wearing if severe discomfort or irritation occurs. DO NOT wear more than one device at a time. Incorrect handling, excessive force, or dropping the device may cause malfunction or permanent damage. DO NOT excessively bend or twist the BioStickerTM. DO NOT wear or use the BioStickerTM during a magnetic resonance imaging

(MRI) procedure or in a location where it will be exposed to strong electromagnetic forces. DO NOT modify or attempt to take the device apart. DO NOT submerge the device in water. The device may be removed for a bath or shower and then re-applied afterwards. Keep the device away from children and pets. The BioStickerTM may be a choking hazard and may be harmful if swallowed. Clinical validation has not been performed on patients who are pregnant, breastfeeding, and those wearing a debrillator or pacemaker. This device is non-sterile. The BioStickerTM is to be worn on the chest. Excessive sweat will reduce wear time. The device may be removed before exercise and then re-applied afterwards. This device contains parts and assemblies susceptible to damage by electrostatic discharge. Wear Instructions Step 1: Prepare the skin R L L e t dry for 1 minute Clean the area with warm water Once the skin is free of excess hair, wipe with a warm, damp cloth. Identify the placement area Upper left chest A couple inches below LEFT collar bone Trim body hair If necessary, remove body hair from the upper left chest with an electric trimmer. Step 2: Prepare the BioStickerTM x10 Press Here Activate the BioStickerTM Press and release the power button. The light should blink. Locate the BioStickerTM and adhesives Locate and remove the BioStickerTM and adhesives from packaging. Apply adhesive to the BioStickerTM Remove the adhesive backings from one side of the adhesive Attach it to black side of the BioStickerTM Step 3: Apply BioStickerTM to Left Chest L 2 Wipe Remove adhesive backings Remove remaining adhesive backings. Apply BioStickerTM to placement area Apply the BioStickerTM to the attest part of your chest, 2 below your collar bone. Apply pressure to the device Press down and apply pressure to ensure good contact with the skin. Wear the device for the prescribed duration. Refer to your physicians instructions for wear time and return instructions. For Best Results:

Press the button on the device to verify that the device is working. The device light should blink. If your device is not blinking, please see Troubleshooting & FAQs. Place the device on the attest part of your left chest, two inches below the collar bone. If the device falls off due to sweat or moisture, dry off the adhesive and reapply. If the device continues to fall off due to low adhesion, remove and replace the adhesive. Then, reapply the device to the placement area. If mild irritation occurs, replace the adhesive to maintain comfort. To allow skin to breathe, place the device in a new location when replacing the adhesive. Wear a shirt while sleeping to keep the device secure. Manufactured by: BioIntelliSense, Inc. 570 El Camino Real #200, Redwood City, CA 94063 Wear Instructions & User Guide Symbol Library FCC icon Consult instructions for use Dont use if package is damaged Type BF applied part Apply by date Date of manufacture Model number Lot number Temperature limitation Humidity limitation Keep dry Latex-free FCC Statement & Legal Notices Model: BIOST0208 FCC ID: 2ASE7- BIOST0208 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 modications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. CAUTION: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. BioIntellisense and Biosticker are trademarks or registered trademarks of BioIntellisense, Inc. Responsible Party:

BioIntellisense, Inc. 570 El Camino Real #200 Redwood City, CA 94063 Our full Notice of Privacy Practices and Terms of Service, found at www.biointellisense.com/legal, describes our privacy practices, our legal duties, and your rights concerning your Protected Health Information (PHI). Technical Specications Product Name: BioSticker Model Number: BIOST0208 Battery: 620mAh, Lithium Coin Cell Operating Conditions:

Temperature Range: 10-40C Humidity Range: 10-95% RH Atmospheric Pressure: 70-102 kPa Water Resistance: IPX8 Heart Rate Range: 30-130 beats per minute (< 5 beats per minute). Respiratory Rate Range: 10-30 breaths per minute with a mean absolute error of < 3 breaths per minute. 4-42 breaths per minute with a mean absolute error of

< 1.5 breaths per minute. Skin Temperature: Complies with ASTM E1112. Troubleshooting & FAQs Can I shower with my device?

Yes, but showers should be short. We recommend showering with your back against the water and keeping soaps and lotions away. While drying off, hold the BioStickerTM down with one hand. Please do not apply any deodorant or lotion to the application area. Can I swim or bathe with my device?

You should not submerge the device underwater. Baths should be ne as long as the device is kept above water. What activities should I avoid?

Avoid activities that cause excessive sweating. They can cause the BioStickerTM to become loose and shorten wear time. How long should I wear my device for?

Wear your device for the prescribed number of days. If you see moisture in the adhesive or are experiencing mild irritation, replace the adhesives to maintain comfort. Im experiencing some skin irritation, what should I do?

If you are experiencing severe skin irritation, contact support immediately. How do I know my device is working?

Press and release the button on the hexagon side of the device. The device light should blink. If the device is not blinking, wait 2 minutes and try again. Why is my device blinking blue?

Occasionally, the device will perform a system reboot. After the reboot is complete, the light will blink blue. My device isnt blinking at all, what do I do?

The device may have shut down, automatically. To activate the device, press and hold the button for 5 seconds. When you release the button, the light should blink blue. For help, email support@biointellisense.com For additional support, please email support@biointellisense.com

Internal Photo FCC ID: 2ASE7-BIOST0208 Inner Circuit Top View Inner Circuit Bottom View Antenna 1

External Photo FCC ID: 2ASE7-BIOST0208 Front View of The Product Rear View of The Product 1

54.328mm Adhesives (2-pack) Store at room temperature. Model: BIOST0208 Lot: 19I131D1 Exp. Date:

FCC ID: 2ASE7- BIOST0208 Manufactured by: BioIntellisense, Inc. 2020-10 m m 3 5 7

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BioIntelliSense, Inc. Agent Authorization Letter 2019-06-12 MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 RE: LETTER OF AGENT AUTHORIZATION To Whom It May Concern:

We, the undersigned, hereby authorize (The Hong Kong Standards and Testing Centre Limited) to act on our behalf in all matters relating to application for equipment authorization, including the signing of all documents relating to these matters. We also hereby certify that no party to the application authorized hereunder is subject to the denial of benefits, including FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C.853(a). This agreement expires one year from the current date. Sincerely, Print nameTracy Cheng Title: Head of Manufacturing Signature:

BioIntelliSense, Inc. Long Term Confidentiality Request Letter 2019-06-12 MET Laboratories, Inc. 914 West Patapsco Avenue Baltimore, MD 21230 RE: CONFIDENTIALITY REQUEST FOR (BioSticker / BIOST0208 /FCC ID:

2ASE7-BIOST0208 ) To Whom It May Concern:

This letter serves as an official request for confidentiality under sections 0.457 and

(block 0.459 diagram/schematics/PCB/BOM/operational description) required to be submitted with this application be permanently withheld from public review. The above documents are company proprietary information that could never get into the possession of my competition. Please contact me if there is any information you may need. Sincerely, Print nameTracy Cheng Title: Head of Manufacturing Signature:

of CFR requested We have that 47. the