2AUA2CS-CB-BLUBluetooth Patient Call Button

Patient Call Button for COOLSCULPTING® ELITE (EN) 2 Ръководство за отстраняване на неизправности (BG) 3 Tlačítko volání pacienta pro systém COOLSCULPTING® ELITE (CS) 4 Patientkald-knap til COOLSCULPTING® ELITE (DA) 5 Patientenruftaste COOLSCULPTING® ELITE (DE) 6 Κουμπί κλήσης ασθενούς για το COOLSCULPTING® ELITE (EL) 7 Botón de llamada del paciente para COOLSCULPTING® ELITE (ES) 8 Süsteemi COOLSCULPTING® ELITE patsiendi kõne nupp (ET) 9 COOLSCULPTING® ELITE -järjestelmän potilaskutsupainike (FI) 10 Bouton d’appel du patient pour COOLSCULPTING® ELITE (FR) 11 Pacijentov gumb za poziv za COOLSCULPTING® ELITE (HR) 12 Orvoshívó gomb a COOLSCULPTING® ELITE rendszerhez (HU) 13 Pulsante Chiamata paziente per COOLSCULPTING® ELITE (IT) 14 Sistemos COOLSCULPTING® ELITE paciento iškvietimo mygtukas (LT) 15 Pacienta zvana poga COOLSCULPTING® ELITE (LV) 16 Patiëntenoproepknop voor COOLSCULPTING® ELITE (NL) 17 Pasientoppringingsknapp for COOLSCULPTING® ELITE (NO) 18 Przycisk wezwania przez pacjenta stosowany z systemem COOLSCULPTING® ELITE (PL) 19 Botão Chamada do paciente para COOLSCULPTING® ELITE (PT) 20 Buton Pacientul sună pentru COOLSCULPTING® ELITE (RO) 21 Tlačidlo volania pacienta pre systém COOLSCULPTING® ELITE (SK) 22 Gumb za klic bolnika sistema COOLSCULPTING® ELITE (SL) 23 Patientsamtalsknapp för COOLSCULPTING® ELITE (SV) 24 ZELTIQ Aesthetics, Inc. 4410 Rosewood Drive Pleasanton, CA 94588, USA www.coolsculpting.com Pat. www.coolsculpting.com/patents Authorized Representative Emergo Europe Prinsessegracht 20 2514 AP, The Hague, The Netherlands ZELTIQ Customer Service Worldwide: (+1) 925-474-8160 USA: (+1) 888-935-8471 (1-888-ZELTIQ1) CS-307176-B2 Note: The blue lanyard covers the side and back of the white Patient Call Button. The blue lanyard strap is for the customer to hold onto during treatment. Patient Call Button for COOLSCULPTING® ELITE (EN) 1. From the Tools menu, tap Settings. The Settings menu appears under the Tools menu. 2. From the Settings menu, tap Patient Call. The Patient Call screen appears. 3. Press down on the grey snowflake icon on the Patient Call Button to activate it. 4. Tap Scan. When you see your Patient Call Button listed, tap Pair. Confirm that the serial number displayed on the screen matches the Patient Call Button to be used. Remove the blue lanyard to see the serial number on the back side of the white Patient Call Button. Note: The specific Patient Call Button will highlight blue on the screen when selected. If the button is awake, it will move from paired to connected. Note: If there is a Patient Call Button already in use, the screen message will request to unpair the paired/connected Patient Call Button first. Follow the steps below within “To disconnect or replace a Patient Call Button or use the same Patient Call Button with a different COOLSCULPTING® ELITE system.” Note: Only one Patient Call Button can be paired with a COOLSCULPT- ING® ELITE system. 5. After pairing, the status will update to connected. The Patient Call Button is now ready for sending notifications. 6. Return to the Tools menu or exit the Tools session: a. Tap Back to return to the Tools menu. b. Tap the close button on the bottom left of the screen to return to the treatment session. This document provides instructions for use for the Patient Call Button for the CoolSculpting Elite System. Please refer to the user manual for the Intended Use, Contraindications, Warnings, Precautions, Adverse Events and detailed instructions on how to use and maintain the CoolSculpting Elite System. The Patient Call Button, used with the CoolSculpting Elite system, is a wireless means for the patient to contact the practitioner during a treatment. Unauthorized changes or modifications not expressly approved by ZELTIQ can void the user’s authority to operate the equipment. The Patient Call screen allows you to pair the system with a Patient Call Button. Note: The Patient Call Button goes to sleep after 3 minutes of inactivity when the COOLSCULPTING® ELITE system is powered off. To activate the Patient Call Button, press down on the grey snowflake icon. 1. Within the Tools menu, wait until the connection confirmation appears before sending notifications from the Patient Call Button. 2. Press down on the grey snowflake icon on the Patient Call Button to send a notification. A bell icon on the upper right of the menu bar should illuminate, which can occur remotely. An audible feedback will occur as well. 3. Tap on the illuminated bell icon to turn it off in order to allow the patient to utilize the Patient Call Button during treatment. 1. From the Tools menu, tap Settings. The Settings menu appears under the Tools menu. 2. From the Settings menu, tap Patient Call. The Patient Call screen appears. 3. Confirm that the serial number displayed on the screen matches the Patient Call Button to be disconnected. Tap Unpair. 4. Follow above steps “To select a Patient Call Button to pair.” Confirm that the Patient Call Button is ready for sending notifications To disconnect or replace a Patient Call Button or use the same Patient Call Button with a different COOLSCULPTING® ELITE system: Cleaning the Patient Call Button 1. Approved cleaning products include: a. Damp towel or water-based wipe b. Isopropyl alcohol c. Mild detergent and warm water d. PDI Sani Cloth Plus wipes 2. Dampen a towel with a cleaning solution or use a water-based or cleaning solution wipe. 3. Wipe down the Patient Call Button and the blue lanyard. Do not submerge in water. The Patient Call Button has been tested and found to comply with the limits for a Class A digital device, pursuant to parts 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio com…

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February 17, 2021 Eurofins MET Labs 914 West Patapsco Avenue Baltimore, MD 21230 RE: Long Term Confidentiality Request For: Bluetooth Patient Call Button, FCC ID: 2AUA2CS-CB-BLU To Whom It May Concern: Pursuant to Section 0.459(b) of the Commission’s Rules, 47 CFR § 0.459(b), Allergan Inc. requests long-term Confidentiality of following sections of this application. Schematics Block Diagrams Operational Description These documents contain detailed system and equipment descriptions and related information about the product, which Allegan Inc. considers to be proprietary, confidential, and a custom design and otherwise, would not release to the general public. Since this design is a basis from which future technological products will evolve, Allergan Inc feels that this information would be of benefit to its competitors, and that the disclosure of the information in these documents would give our competitors an unfair advantage in the market. Please contact me if there is any information you may need. Sincerely, _______________________________ Saurabh Jamkhindikar Regulatory Affairs Manager [email protected] Allergan Inc February 17, 2021

December 16, 2020 Eurofins MET Labs 914 West Patapsco Avenue Baltimore, MD 21230 RE: Short Term Confidentiality Request For: Bluetooth Patient Call Button, FCC ID: 2AUA2CS-CB-BLU To Whom It May Concern: In accordance with sections 0.457 and 0.459 of CFR 47, Allergan Inc. requests short- term Confidentiality of following sections of this application for a period of 45 days after grant is issued. Test setup photos Schematics and Block Diagrams External photos Internal photos User’s manual These documents contain detailed system and equipment descriptions and related information about the product, which Allegan Inc. considers to be proprietary, confidential, and a custom design and otherwise, would not release to the general public. Since this design is a basis from which future technological products will evolve, Allergan Inc feels that this information would be of benefit to its competitors, and that the disclosure of the information in these documents would give our competitors an unfair advantage in the market. Please contact me if there is any information you may need. Sincerely, _______________________________ Zane Wilson Assoc Director, Product Development [email protected] Allergan Inc DocuSign Envelope ID: 27F38D95-9EE1-452A-8F95-718957471424 December 16, 2020

REV DWG NO: SHEET SCALE: A TITLE: GENERAL DIMENSIONAL TOLERANCES DRAWN BY: CHECKED: THIRD ANGLE PROJECTION .XX ± HOLES FRAC. ANG. .01 .021/161 1:1 1 OF 1 T.Hilton .X ± .3 DESCRIPTION REVISIONS REV DATE APPROVED PER ARENA PER ARENA PER ARENA A A CS-306010 Art, LBL, Disc, Bluetooth Call Button Not a CREO le DO NOT SCALE ART NOTES (UNLESS OTHERWISE SPECIFIED): 1. APPLICABLE STANDARDS/SPECIFICATIONS ASME Y14.5-2018, DIMENSIONS AND TOLERANCES. ASME Y14.38-2019, ABBREVIATIONS AND ACRONYMS 2. Greyed text and barcode represent variable data input 3. Keyence Laser Marking Settings: Laser Power: 80% Scan Speed: 1500 mm/s Pulse Frequency: 40 kHz 4. Editable text on ‘native layer” of .ai file locked and hidden. C S R Y Y Y Y D D D X X X C S - C B - B L U - 0 1 - 0 0 CS-306010-A FCC ID: 2AUA2CS-CB-BLU IC ID:11209A-CSCBBLU0100 30mm (±2mm) 30mm (±2mm) SN This document contains or represents confidential and proprietary information of Zeltiq Aesthetics, Inc., an AbbVie company and may not be copied, disclosed, or used, in whole or in part, without the prior consent of Zeltiq Aesthetics, Inc. Zeltiq Aesthetics 4410 Rosewood Dr. Pleasanton, CA 94588 Copyright © 2020 AbbVie All rights reserved. an company

Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932-FCC-Internal Photos Rev 0 © 2020, Eurofins E&E North America Page 1 of 2 Photograph Set 1. Outer Cover Removed Photograph Set 2. PCB front and back (showing batttery) Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932-FCC-Internal Photos Rev 0 © 2020, Eurofins E&E North America Page 2 of 2 Photograph 3. BLE Antenna Location BLE Antenna

Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button Antenna Datasheet Report: WIRS109932- FCC – Antenna Spec Rev 0 © 2020, Eurofins E&E North America Page 1of 1 Antenna Gain Measurements TX Frequency (MHz) Output Power (dBm) TRP Run EIRP Efficiency (%) Peak Gain (dBi) 2402 -0.672 -7.91285 -0.9 18.9 -0.2 2442 -0.68 -8.15866 -1.2 17.9 -0.5 2480 -1.205 -7.94494 -1.3 21.2 -0.1 2402 2442 2480 Total Power (dBm) -40 5 -30 -20 -10 Z XY Azimuth = 270.0 Elevation = -90.0 Roll = 90.0 Total Power (dBm) -35 5 -25 -15 -5 X Z Y Azimuth = 270.0 Elevation = -90.0 Roll = 90.0 Total Power (dBm) -45 5 -35 -25 -15 -5 Z XY Azimuth = 270.0 Elevation = -90.0 Roll = 90.0

Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932- FCC - MPE Rev 0 © 2020, Eurofins E&E North America Page 1 of 2 Electromagnetic Compatibility Criteria for Intentional Radiators § 15.247(i) Maximum Permissible Exposure RF Exposure Requirements: §1.1307(b)(1) and §1.1307(b)(2): Systems operating under the provisions of this section shall be operated in a manner that ensures that the public is not exposed to radio frequency energy levels in excess of the Commission’s guidelines. RF Radiation Exposure Limit: §1.1310: As specified in this section, the Maximum Permissible Exposure (MPE) Limit shall be used to evaluate the environmental impact of human exposure to radiofrequency (RF) radiation as specified in Sec. 1.1307(b), except in the case of portable devices which shall be evaluated according to the provisions of Sec. 2.1093 of this chapter. Table 1. RF Exposure Limits Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932- FCC - MPE Rev 0 © 2020, Eurofins E&E North America Page 2 of 2 S = PG / 4π ππ πR 2 or R = √(PG / 4π ππ πS) where, S = Power Density (mW/cm 2 ) P = Power Input to antenna (mW) G = Antenna Gain (numeric value) R = Distance (cm) For Antenna Gain
dBi = 10log(Numeric) Antenna Type: Manufacturer Gain (dBi): Impedance Polarization PCB Trace Allergan 2402 MHz: -0.2 dBi 2442 MHz: -0.5 dBi 2480 MHz: -0.1 dBi 50
Linear Table 2. Antenna Specification Test Results: Frequency (MHz) Maximum Rated Conducted Power (dBm) Tune Up Power (dBm) Conducted Power (mW) Antenna Gain (dBi) Antenna Gain (Num) Power Density (mW/cm2) Limit (mW/cm2) Margin Distance (cm) Result 2480 0.0 1.0 1.258 - 0.1 0.977 0.391 1 -0,60 0.5 Pass Table 3. MPE Calculation Tune Up Power: ±1dBm The safe distance where Power Density is less than the MPE Limit listed above was found to be 0.5cm. This distance is provided by the plastic casing of the device. SAR Exclusion Consideration: Per FCC KDB 447498 D01 Section 4.3.1, for 100 MHz to 6 GHz and test separation distances ≤ 50 mm, the 1-g and 10-g SAR test exclusion thresholds are determined by the following: [(max. power of channel, including tune-up tolerance, mW) / (min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR, and ≤ 7.5 for 10-g extremity SAR, Where • f(GHz) is the RF channel transmit frequency in GHz • Power and distance are rounded to the nearest mW and mm before calculation • The result is rounded to one decimal place for comparison • The values 3.0 and 7.5 are referred to as numeric thresholds Therefore [ 1.258 / 5 ] x [√2.480 ] ≤ 3.0 0.2516 x 1.574 ≤ 3.0 0.396 ≤ 3.0
(Pass)

HEADQUARTERS: 914 WEST PATAPSCO AVENUE • BALTIMORE, MARYLAND 21230 • PHONE (410) 354-3300 • FAX (410) 354-3313 Maryland | California | Texas www.metlabs.com November 4, 2020 Allergan 4410 Rosewood Dr Pleasanton, CA 94588 USA Dear Saurabh Jamkhindikar Enclosed is the EMC Wireless test report for compliance testing of the Allergan, Elite CoolSculpting Patient Call Button as tested to the requirements of Title 47 of the CFR, Ch. 1 (10-1-06 ed.), Part 15 Subpart C for Intentional Radiators. Thank you for using the services of Eurofins E&E North America. If you have any questions regarding these results or if we can be of further service to you, please feel free to contact me. Sincerely yours, EUROFINS E&E NORTH AMERICA Arsalan Hasan Wireless Laboratory Reference: (\Allergan\WIRS109932-FCC247 BLE Rev 0) Certificates and reports shall not be reproduced except in full, without the written permission of Eurofins E&E North America. This letter of transmittal is not a part of the attached report. Eurofins MET Laboratories Inc. (Eurofins E&E North America) is part of the Eurofins Electrical & Electronics (E&E) global compliance network. Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932-FCC247 BLE Rev 0 © 2020, Eurofins E&E North America Page ii of viii Electromagnetic Compatibility Criteria Test Report for the Allergan Elite CoolSculpting Patient Call Button Tested under the FCC Certification Rules contained in 15.247 Subpart C for Intentional Radiators Report: WIRS109932-FCC247 BLE Rev 0 November 4, 2020 Prepared For: Allergan 4410 Rosewood Dr, Pleasanton, CA 94588 USA Prepared By: Eurofins E&E North America 3162 Belick Street Santa Clara, CA 95054 Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932-FCC247 BLE Rev 0 © 2020, Eurofins E&E North America Page iii of viii Electromagnetic Compatibility Criteria Test Report for the Allergan Elite CoolSculpting Patient Call Button Tested under the FCC Certification Rules contained in 15.247 Subpart C for Intentional Radiators Felix Huang Arsalan Hasan Engineer, Wireless Laboratory Manager, Wireless Laboratory Engineering Statement: The measurements shown in this report were made in accordance with the procedures indicated, and the emissions from this equipment were found to be within the limits applicable. I assume full responsibility for the accuracy and completeness of these measurements, and for the qualifications of all persons taking them. It is further stated that upon the basis of the measurements made, the equipment tested is capable of operation in accordance with the requirements of the FCC Rules Part 15.247 under normal use and maintenance. Eleazar Zuniga, PhD. Director, Wireless Technologies Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932-FCC247 BLE Rev 0 © 2020, Eurofins E&E North America Page iv of viii Report Status Sheet Revision Report Date Reason for Revision 0 November 4, 2020 Initial Issue. Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932-FCC247 BLE Rev 0 © 2020, Eurofins E&E North America Page v of viii Table of Contents I. Executive Summary ................................................................................................................................................ 1 A. Purpose of Test ................................................................................................................................................... 2 B. Executive Summary ........................................................................................................................................... 2 II. Equipment Configuration ....................................................................................................................................... 3 A. Overview ............................................................................................................................................................ 4 B. References .......................................................................................................................................................... 5 C. Test Site.............................................................................................................................................................. 5 D. Description of Test Sample ................................................................................................................................ 5 E. Equipment Configuration ................................................................................................................................... 5 F. Support Equipment ............................................................................................................................................. 6 G. Ports and Cabling Information ........................................................................................................................... 6 H. Mode of Operation ............................................................................................................................................. 7 I. Method of Monitoring EUT Operation .............................................................................................................. 7 J. Modifications ..................................................................................................................................................... 7 a) Modifications to EUT ................................................................................................................... 7 b) Modifications to Test Standard ..................................................................................................... 7 K. Disposition of EUT ............................................................…

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Allergan Electromagnetic Compatibility Elite CoolSculpting Patient Call Button CFR Title 47, Part 15.247 Report: WIRS109932- FCC - Setup Photos Rev 0 © 2020, Eurofins E&E North America Page 1of 1 Photograph 1: Radiated Spurious Emissions, Below 1GHz, Test Setup Photograph 2: Radiated Spurious Emissions, Above 1GHz, Test Setup