2BBOF-CAIPLUSDepth of Anesthesia Monitoring System

CAI+ Instruction for Use IFU-01 Ver 1.0.0 2023.08.09 CAI+ Instruction for Use IFU-01 Ver 1.0.0 2023.08.09 Contents I.Introduction of CAI+····························································································1 A. Product description························································································1 1.Scope··························································································································1 2.Manufacturer information························································································1 3.CAI+ Monitoring System Overview·······································································2 4.CAI+Monitoring System’s key features are as follows:·····································3 B. CAI+Monitoring System’s Basic Configuration···········································4 1.CAI+ Main Body ·····································································································5 2.Monitor(Tablet) / CAI+ Application·······································································6 3.Sensor Cable ············································································································7 4.Snap Electrode··········································································································7 5.Adapter / Cable (for CAI+ Main Body) ······························································8 6.Instruction for Use ··································································································9 7.CAIs Sensor ··············································································································10 8.Disposable Electrode ······························································································11 C. CAI+ Monitoring System Specification ·······················································12 1.CAI+ Monitoring System Specification·································································12 2.Wireless (Bluetooth) Specification··········································································12 3.Operating Frequency Range & Transmit Power·················································12 4.Antenna Gain·············································································································12 D. Use Environment ···························································································13 II.Operation Method of CAI+ Monitoring System············································15 A. Preparation before use ················································································15 B. Connecting CAI+ ···························································································20 C. How to use ····································································································23 D. After use ········································································································40 E. Cleaning ··········································································································40 III.Caution / Maintenance ····················································································41 A. Caution / Safety Actions ·············································································41 1.Caution ·····················································································································41 2.Safety Actions ··········································································································46 3.label and marking information··············································································48 B. Maintenance ···································································································51 C. CAI+ checks ···································································································53 D. Warranty Information ···················································································54 E. Wireless Certification Information ·······························································58 - 1 - I. Introduction of CAI+ A. Product description CAI+ is a system that records electrical activity signals in the brain by attaching more than one electrode to the patient's head, and is a medical device that provides medical staff with information on the patient's level of consciousness during surgery. 1.Scope I t e m Depth of Anesthesia Monitoring SystemRatingClass 2 M o d e l n a m eCAI+ ManufacturerBrainU Co., Ltd. C o u n t r y o f M a n ufa c t u r e Republic of korea 2.Manufacturer information 1)Manufacturer : BrainU Co., Ltd. 2)Address : 3F, 7, Yatap-ro 105beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea (13506) 3)Customer Service (1)TEL : 031-707-1788 (2)e-mail : [email protected] (3)Website : eng.brainu.co.kr/ - 2 - 3.CAI+ Monitoring System Overview CAI+ is a system providing patient’s consciousness level through their brainwave analysis during surgical procedure to medical staffs, and the system comprises with CAIs-Sensor (brainwave sensor), CAI+ Main Body (amplification module), CAI+ algorithms for calculation and analysis and Tablet. CAI+ Monitoring System, which has capability of setting various conditions, is designed to monitor anesthetic state of brain by collecting and analyzing brainwaves. CAI+ Monitoring System provides digitalized information through operational processing of unprocessed EEG signals. This processed information, which is called arousal index (AI) or CAI index, is closely correlated with arousal degree of a patient. Users can change data indications and review stored data via menus on the touch screen display. Intended propose of CAI+ Monitoring System CAI+ Monitoring System is a device that records and analyzes the electrical signal activity of the brain by attaching two or more electrodes around the patient's forehead…

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V02072023 Manufacturers Letterhead Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 10/10/2023 Ref: Attestation Statement Part 2.911(d)(7) Filing FCC ID:2BBOF-CAIPLUS BrainU Co., Ltd. certifies that, as of the dates of this application, Americas Compliance Consulting LLC dba iCertifi “iCertifi” is our designated U.S. agent for service of process for the above referenced FCC ID. BrainU Co., Ltd. accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any commission-related proceeding involving the equipment. iCertifi accepts, as of the date of the filing of the application, the obligation of the designated U.S. agent for service process for the above referenced FCC ID. Designated U.S. Agent Information: Name: Americas Compliance consulting, LLC dba iCertifi FCC FRN: 0033399411 Address: 1001 SW Disk Drive, Suite 250, Bend, Oregon 97702 Contact Person: Paul Preston Tel: 866-885-4575 Email: [email protected] Sincerely, BrainU Co., Ltd. FRN: 0033892423 Americas Compliance Consulting LLC dba iCertifi Sang-woo Choi Paul Preston Signature

Subject : Covered List Attestation Letter (Section 2.911 (d)(5)(i)(ii)) Date: 9/25/2023 FCC ID: 2BBOF-CAIPLUS To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA BrainU Co., Ltd. certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section 2.903 of the FCC rules. 2.911 (d)(5)(i)(ii) And, we certifies that one of following, ☒ 1. We are not identified on the Covered List and are not an affiliate or subsidiary of an entity identified on the Covered List. ☐ 2. We are identified on the Covered List as an entity producing “covered” equipment. But, we can be authorized since the reason as explained below. ☐ 3. We are an affiliate or subsidiary of an entity identified on the Covered List. But, we can be authorized since the reason as explained below. *Only one of paragraphs 1, 2 or 3 should be checked, if checked on paragraphs 2 or 3, the reason why it does not include the “covered” equipment should be addressed. Sincerely yours, (Name) Sang-woo Choi (Title) Deputy Department Manager (Company Name) BrainU Co., Ltd.

Date: To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD To whom it may concern: Subject : FCC Agent Authorization Letter for FCC ID :2BBOF-CAIPLUS This authorization is valid until further written notice from the applicant. Sincerely, Signed by: (Name) Sang-woo Choi (Title) Deputy Department Manager [email protected] 82-31-707-1788 (Address) September 25, 2023 3F, 7, Yatap-ro 105beongil, Bundang-gu, Sengnam-si, Gyeonggi-do, Republic of Korea We, the undersigned, hereby authorize HCT CO., LTD. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by HCT CO., LTD. on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). We recognize that we are still responsible for the terms and conditions outlined in the HCT America Client Services Agreement. ___________________________________ (Email Address) (Phone number)

Date: To: Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD SUBJECT: Request for Confidentiality for FCC ID:2BBOF-CAIPLUS We hereby request confidential treatment of the information accompanying this application as outlined below: Exhibit 1 2 3 4 5 6 7 8 Sincerely, Signed by: (Name) Sang-woo Choi (Title) Deputy Department Manager (Email Address) [email protected] (Phone number) 82-31-707-1788 (Address) 3F, 7, Yatap-ro 105beongil, Bundang-gu, Sengnam-si, Gyeonggi- do, Republic of Korea September 25, 2023 Description Block Diagram Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that pursuant to Section 0.457 & 0.459 of the Rules, disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. LONG-TERM CONFIDENTIAL SHORT-TERM CONFIDENTIAL (180 DAYS) User’s Manual Test-Setup Photos Internal Photos External Photos Schematics Parts List LONG-TERM AND SHORT-TERM CONFIDENTIAL LIST

FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401. External Photos FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401.  EXTERNAL PHOTO (CAI+ Main body) FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401.  EXTERNAL PHOTO(CAI+ Main body) FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401.  EXTERNAL PHOTO (CAI+ Sensor Cable)  EXTERNAL PHOTO (Medical Power Supply) FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401.  EXTERNAL PHOTO (CAIs Sensor)  EXTERNAL PHOTO (Snap electrode)

CAI Plus (Left side of the device) 80 mm 25 mm CAI+ (Depth of Anesthesia Monitoring System) BrainUCo., Ltd. 3F, 7, Yatap-ro 105beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea RatePower: Input 100-240 V~ 50-60 Hz 0.5 A Output +5 V 2.0 A Battery: Lithium Polymer 3.7 V 2,000 mAh R020-230125 S N #000000 R : 0 G : 0 B : 0 #195099 R : 25 G : 80 B : 153 #FFF100 R : 255 G : 241 B : 0 ISO 7010 –M002 ISO 7000 –0434A IEC60417-5333 WEEE ISO 7000-2497 ISO 7000-2498 S N ISO 7000-3082 ISO 7000 -2606ISO 7000 -0623ISO 7000 -0621ISO 7000 -0626 FCC ID: 2BBOF-CAIPLUS Contains FCC ID : 2AAQS-ISP1807

FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401. Internal Photos FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401. (Internal Photo-Main Board) (Internal Photo-Main Board) FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401. (Internal Photo – Antenna and Certified module) RF Module and Antenna FCC ID: 2BBOF-CAIPLUS (주) 에 이 치 시 티 TEL : 031-645-6300 FAX: 031-645-6401. (Internal Photo-AFE Board) (Internal Photo-AFE Board)

HCT Co., Ltd. 74, Seoicheon-ro 578beon-gil, Majang-myeon, Icheon-si, Gyeonggi-do, 17383 KOREA Tel. +82 31 645 6300 Fax. +82 31 645 6401 F-TP22-03 (Rev. 04) Page 2 of 25 TE S T R E P O R T E M I T e s t f o r F C C C e r t i f i c a t i o n REPORT NO. HCT-EM-2309-FC001 DATE OF ISSUE September 18, 2023 FCC ID. 2BBOF-CAIPLUS Applicant BrainU Co., Ltd. 3F, 7, Yatap-ro 105beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do, Republic of Korea Product Name Model Name Depth of Anesthesia Monitoring System CAI+ Date of Test September 07, 2023 to September 11, 2023 Test Standard Used FCC CFR 47 PART 15 Subpart B Class A ANSI C63.4-2014 Test Results Refer to the present document Manufacturer BrainU Co., Ltd. The result shown in this test report refer only to the sample(s) tested unless otherwise stated. This test results were applied only to the test methods required by the standard. F-TP22-03 (Rev. 04) Page 3 of 25 Report No. HCT-EM-2309-FC001 REVISION HISTORY The revision history for this test report is shown in table. Revision No. Date of Issue Description 0 September 18, 2023 Initial Release The above Test Report is not related to the accredited test result by (KS Q) ISO/IEC 17025 and KOLAS(Korea Laboratory Accreditation Scheme), which signed the ILAC-MRA. If this report is required to confirmation of authenticity, please contact to www.hct.co.kr F-TP22-03 (Rev. 04) Page 4 of 25 Report No. HCT-EM-2309-FC001 CONTENTS 1. GENERAL INFORMATION 5 1.1 Description of EUT 5 1.2 Tested System Details 5 1.3 Cable Description 6 1.4 Noise Suppression Parts on Cable (I/O Cable) 7 1.5 Test Facility 8 1.6 Calibration of Measuring Instrument 8 1.7 Measurement Uncertainty 8 2.DESCRIPTION OF TESTING 9 2.1 Measurement of Conducted Emission 9 2.2 Configuration of Tested System 12 3. OPERATION OF THE EUT 13 4. MEASURING INSTRUMENTS14 5. EMISSION TEST SUMMARY15 5.1 Conducted Emission 15 5.2 Radiated Emission Below 1 ㎓ 20 5.3 Radiated Emission Above 1 ㎓ 22 6 APPENDIX A. TEST SETUP PHOTO 25 F-TP22-03 (Rev. 04) Page 5 of 25 Report No. HCT-EM-2309-FC001 1.GENERAL INFORMATION 1.1 Description of EUT FCC ID 2BBOF-CAIPLUS Product Name Depth of Anesthesia Monitoring System Model Name CAI+ Internal Clock Main processor maximum operation clock: 100 ㎒ Wireless transceiver input clock: 32 ㎒ Frequency Range Bluetooth: 2 402 ㎒ to 2 480 ㎒ Power Voltage AC 100 to 240 V, 0.5 A Battery: DC 3.7 V, 2 000 mAh Manufacturer BrainU Co., Ltd. 1.2 Tested System Details All equipment descriptions used in the tested system (including inserted cards) are: Device Type Model Name Serial Number Manufacturer Depth of Anesthesia Monitoring System CAI+ - BrainU Co., Ltd. Medical Power Supply* BM010S05F - Bridge Power Corp. Arbitrary Function Generator AFG-2225 - GWINSTEK Sensor Cable - - BrainU Co.,Ltd Electrodes for scalp brain waves CAIs - Hurev Tablet PC SM-T295N - SAMSUNG *Input: AC 100-240 V, 0.5 A, Output: DC 5 V, 2.0 A F-TP22-03 (Rev. 04) Page 6 of 25 Report No. HCT-EM-2309-FC001 1.3 Cable Description [Adapter] Bluetooth + Sensor Cable Mode Product Name Port Power Cord Shielded (Y/N) I/O Cable Shielded (Y/N) Length (m) EUT Charge/Data N N 1.8 Sensor N N 1.0 Sensor Cable 4 Port N N 1.5 [Adapter] Bluetooth + Electrodes for scalp brain waves Mode Product Name Port Power Cord Shielded (Y/N) I/O Cable Shielded (Y/N) Length (m) EUT Charge/Data N N 1.8 Sensor N N 1.0 Electrodes for scalp brain waves 4 Port N N 1.5 [Battery] Bluetooth + Sensor Cable Mode Product Name Port Power Cord Shielded (Y/N) I/O Cable Shielded (Y/N) Length (m) EUT Sensor N N 1.0 Sensor Cable 4 Port N N 1.5 [Battery] Bluetooth + Electrodes for scalp brain waves Mode Product Name Port Power Cord Shielded (Y/N) I/O Cable Shielded (Y/N) Length (m) EUT Sensor N N 1.0 Electrodes for scalp brain waves 4 Port N N 1.5 F-TP22-03 (Rev. 04) Page 7 of 25 Report No. HCT-EM-2309-FC001 1.4 Noise Suppression Parts on Cable (I/O Cable) [Adapter] Bluetooth + Sensor Cable Mode Product Name Port Ferrite Bead (Y/N) Location Metal Hood (Y/N) Location EUT Charge/Data Y End of EUT Y Both Sensor N N Y Both Sensor Cable 4 Port N N N N [Adapter] Bluetooth + Electrodes for scalp brain waves Mode Product Name Port Ferrite Bead (Y/N) Location Metal Hood (Y/N) Location EUT Charge/Data Y End of EUT Y Both Sensor N N Y Both Electrodes for scalp brain waves 4 Port N N N N [Battery] Bluetooth + Sensor Cable Mode Product Name Port Ferrite Bead (Y/N) Location Metal Hood (Y/N) Location EUT Sensor N N Y Both Sensor Cable 4 Port N N N N [Battery] Bluetooth + Electrodes for scalp brain waves Mode Product Name Port Ferrite Bead (Y/N) Location Metal Hood (Y/N) Location EUT Sensor N N Y Both Electrodes for scalp brain waves 4 Port N N N N F-TP22-03 (Rev. 04) Page 8 of 25 Report No. HCT-EM-2309-FC001 1.5 Test Facility Test site is located at 74, Seoicheon-ro 578beon-gil, Majang-myeon, Icheon-si, Gyeonggi-do, Korea. Those measurement facilities are constructed in conformance with the requirements of ANSI C63.4-2014. The Normalized site attenuations (30 ㎒ to 1 ㎓) and Site validation (1 ㎓ to 18 ㎓) were performed in accordance with the standard in ANSI C63.4-2014 and ANSI C63.4a-2017 Our laboratories are accredited and designated in accordance with the provisions of Radio Waves ACT and International Standard ISO/IEC 17025:2017. (National Radio Research Agency, CABID No. KR0032) 1.6 Calibration of Measuring Instrument The measuring equipment, which was utilized in performing the tests documented herein, has been calibrat ed in accordance with the manufacturers recommendations for utilizing calibration equipment, which is traceable to recognized national standards.Espectially, all antenna for measurement is calibrated in accordance with the requirements of C63.5:2017 1.7 Measurement Uncertainty The measurement uncertainties shown below were calculated in accordance with the requirements of ANSI C63.4-2014. All measurement uncertainty values are shown with a coverage factor of k = 2 to indicate a 95 % level of confidence. The measurement…

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File No. HCT-EM-2309-FC001-P Page 1 of 11 HCT Co., Ltd. 74, Seoicheon-ro 578beon-gil, Majang-myeon, Icheon-si, Gyeonggi-do, 17383 KOREA Tel. +82 31 645 6300 Fax. +82 31 645 6401 A p p e n d i x A : T e s t S e t u p P h o t o Model Name. CAI+ File No. HCT-EM-2309-FC001-P REVISION HISTORY The revision history for this document is shown in table. Revision No. Date of Issue Description 0 September 18, 2023 Initial Release File No. HCT-EM-2309-FC001-P Page 2 of 11 Model Name. CAI+ A.1 Conducted Emission [Adapter] Bluetooth + Sensor Cable Mode File No. HCT-EM-2309-FC001-P Page 3 of 11 Model Name. CAI+ [Adapter] Bluetooth + Electrodes for scalp brain waves Mode File No. HCT-EM-2309-FC001-P Page 4 of 11 Model Name. CAI+ A.2 Radiated Emission below 1 ㎓ [Adapter] Bluetooth + Sensor Cable Mode File No. HCT-EM-2309-FC001-P Page 5 of 11 Model Name. CAI+ [Adapter] Bluetooth + Electrodes for scalp brain waves Mode File No. HCT-EM-2309-FC001-P Page 6 of 11 Model Name. CAI+ [Battery] Bluetooth + Sensor Cable Mode File No. HCT-EM-2309-FC001-P Page 7 of 11 Model Name. CAI+ [Battery] Bluetooth + Electrodes for scalp brain waves Mode File No. HCT-EM-2309-FC001-P Page 8 of 11 Model Name. CAI+ A.3 Radiated Emission above 1 ㎓ [Adapter] Bluetooth + Sensor Cable Mode File No. HCT-EM-2309-FC001-P Page 9 of 11 Model Name. CAI+ [Adapter] Bluetooth + Electrodes for scalp brain waves Mode File No. HCT-EM-2309-FC001-P Page 10 of 11 Model Name. CAI+ [Battery] Bluetooth + Sensor Cable Mode File No. HCT-EM-2309-FC001-P Page 11 of 11 Model Name. CAI+ [Battery] Bluetooth + Electrodes for scalp brain waves Mode End of report