FCC ID: 2BDH3ASY300056 455nm 30W surgical laser that reads RFID chip in fiber optic devices

InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 InnoVoyce Surgical Laser User Manual 1 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 2023, InnoVoyce. All rights reserved. No part of this manual may be reproduced or copied in any form by any means - graphic, electronic or mechanical, including photocopying, typing, or information retrieval systems -

without written permission of InnoVoyce System specifications and the information contained in this document are subject to change without notice. InnoVoyce, its logo and the Surgical Laser are either registered trademarks or trademarks of InnoVoyce Inc. in the USA and/or other countries. InnoVoyce One Beacon St Floor 15 Boston, MA 02108 1 617 865 9401 Info@InnoVoyce.com https://innovoyce.com/

Revision Number/Date Caution: Federal Law restricts this device to sale by or on the order of a physician. Rx Ony. 2 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 1 CONTENTS 2 Introduction .......................................................................................................................................... 6 2.1 2.2 2.3 2.4 Use of the Operator Manuals ....................................................................................................... 6 User Profiler / Intended User ........................................................................................................ 7 Intended Use ................................................................................................................................. 7 Physician Responsibility ................................................................................................................ 7 2.5 Maintenance ................................................................................................................................. 7 2.6 Modification of the System or Accessories ................................................................................... 8 2.7 Abbreviations and Acronyms ....................................................................................................... 8 3 Safety .................................................................................................................................................... 8 3.1 3.2 3.3 The Treatment Room .................................................................................................................... 8 System Safety Measures ............................................................................................................... 9 Electrical Safety ............................................................................................................................. 9 3.3.1 Light Safety.............................................................................................................................. 10 3.3.2 Smoke Evacuation and Laser Plume Pollution Hazards .......................................................... 10 3.4 General Precautions and Cautions .............................................................................................. 10 3.4.1 Precautions ............................................................................................................................. 10 3.4.2 Cautions .................................................................................................................................. 11 3.5 Warnings Related to Energy Emission ........................................................................................ 11 3.5.1 Burn Hazards ........................................................................................................................... 11 3.5.2 Direct and Reflected Eye Exposure Hazards ........................................................................... 11 3.5.3 Laser Safety Eyewear .............................................................................................................. 12 3.5.4 High Voltage Hazards .............................................................................................................. 13 3.5.5 Grounding the System ............................................................................................................ 13 3.6 3.7 3.8 3.9 System Safety Features ............................................................................................................... 13 System and Equipment Classifications and Compliance ............................................................. 14 Labeling and Signs ....................................................................................................................... 14 Contraindications ........................................................................................................................ 18 4 System Description ............................................................................................................................. 18 4.1 4.2 General System Description ........................................................................................................ 18 System Specifications .................................................................................................................. 18 3 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 4.3 System Components and Controls .............................................................................................. 20 4.3.1 Control Panel .......................................................................................................................... 20 4.3.2 Display ..................................................................................................................................... 21 4.3.3 Laser Fiber ............................................................................................................................... 21 4.3.4 Microscope filter ..................................................................................................................... 22 4.3.5 Cooling System ........................................................................................................................ 22 4.3.6 Emergency Shut-Off ................................................................................................................ 22 4.3.7 Emission Indicators ................................................................................................................. 22 4.3.8 Rear Panel ............................................................................................................................... 23 4.3.9 Main Power Switch ................................................................................................................. 23 4.3.10 Footswitch ............................................................................................................................... 23 4.3.11 Remote Interlock .................................................................................................................... 24 5 Installation .......................................................................................................................................... 24 5.1 5.2 Equipment List ............................................................................................................................ 24 Facility Requirements ................................................................................................................. 25 5.2.1 Electrical requirements ........................................................................................................... 25 5.2.2 Environmental Requirements ................................................................................................. 25 5.3 Unpacking the System................................................................................................................. 25 5.4 Moving the system ...................................................................................................................... 26 6 Operating Instructions ........................................................................................................................ 26 6.1 6.2 6.3 6.4 Connecting the System ............................................................................................................... 26 Attaching the microscope filter .................................................................................................. 26 Remote Interlock and Footswitch connection ............................................................................ 26 Operating the System ................................................................................................................. 27 6.4.1 Turning ON the System ........................................................................................................... 27 6.4.2 System Calibration .................................................................................................................. 27 6.4.3 Microscope Filter selection ..................................................................................................... 28 6.4.4 Installing the laser fiber .......................................................................................................... 29 6.5 Treatment modes and parameters ............................................................................................. 30 6.5.1 Pulsed ...................................................................................................................................... 31 6.5.2 Quasi-Pulsed ........................................................................................................................... 31 6.5.3 Continuous .............................................................................................................................. 32 4 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 6.5.4 Aiming Beam ........................................................................................................................... 33 6.5.5 Firing the Laser ........................................................................................................................ 34 6.5.6 Fiber Tip Flare ......................................................................................................................... 35 6.5.7 Returning to Standby .............................................................................................................. 35 6.5.8 Shutting off the System .......................................................................................................... 36 6.6 Treatment Considerations .......................................................................................................... 36 7 Maintenance and cleaning .................................................................................................................. 37 7.1 Maintenance and Cleaning ......................................................................................................... 37 7.2 Cleaning ....................................................................................................................................... 37 7.2.1 Laser Fiber ............................................................................................................................... 37 7.2.2 External Surfaces..................................................................................................................... 37 7.3 7.4 Periodic Service ........................................................................................................................... 38 Service Information ..................................................................................................................... 38 8 Trouble shooting ................................................................................................................................. 38 8.1 System Faults .............................................................................................................................. 39 9 Electromagnetic compatibility ............................................................................................................ 40 10 Essential Performance ........................................................................................................................ 41 11 Disposal of device ............................................................................................................................... 41 Appendix A: Pre-treatment Preparations ................................................................................................... 42 Appendix B: Post Treatment Log Sheet ...................................................................................................... 43 5 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 2 INTRODUCTION InnoVoyce Surgical laser will be a solid-state laser device in which laser energy is generated by internal diodes. The laser output energy of the device is in the bluespectrum at wavelength comprised between 440-450nm. 2.1 USE OF THE OPERATOR MANUALS Warning!

Use of controls or adjustments, or performance of procedures other than those specified herein may result in hazardous radiation exposure. DO NOT operate the system before attempting to use or operate the system, practitioners operating the system should read this manual and become thoroughly familiar with all its safety requirements and operating procedures. 6 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 The system is designed to meet international safety and performance standards. Personnel operating the system must have a thorough understanding of how to properly operate the system. This manual has been prepared to aid medical and technical personnel to understand and operate the system. If any part of this manual is not clear, please contact your InnoVoyce representative for clarification. The information provided in this manual is not intended to replace professional training on the clinical use of the system. Please contact your InnoVoyce representative for current information on available training. This manual should always accompany the system and all operating personnel must know its location. Additional copies of this manual are available from InnoVoyce or your local InnoVoyce representative. For further information about InnoVoyce, visit the company website at:

https://InnoVoyce.com/

2.2 USER PROFILER / INTENDED USER The system is intended to be used by professional practitioners (specialized physician/authorized technical personnel) in the medical field. The system is intended for use in professional healthcare facility environment (such as Physician offices, clinics, hospitals etc.) and intended for indoor environment use only. 2.3 INTENDED USE The InnoVoyce Surgical Laser is intended for use in incision/excision, vaporization, ablation, and coagulation of soft tissue. 2.4 PHYSICIAN RESPONSIBILITY Regulatory statutes in most countries restrict prescription of medical systems for sale by or on the order of a physician, or a properly licensed practitioner. The physician will be responsible for the use and operation of the system and for all operator qualifications. InnoVoyce makes no representations regarding state or local laws or regulations that might apply to the use and operation of any medical system. The physician is responsible for contacting his or her local licensing agencies to determine any credential required by law for clinical use and the operation of the system. 2.5 MAINTENANCE The system requires periodic routine maintenance service, which must be performed by InnoVoyce authorized technical personnel only. Failure to obtain service voids all warranties expressed and implied. Please contact InnoVoyce or your local representative for details. 7 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 2.6 MODIFICATION OF THE SYSTEM OR ACCESSORIES Warning!

No modification of this equipment is allowed. Unauthorized modification of the hardware, software or specifications of the system and its accessories voids all warranties, expressed and implied. InnoVoyce takes no responsibility for the use or operation of such a modified system. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating correctly. 2.7 ABBREVIATIONS AND ACRONYMS 3 SAFETY This chapter describes general safety issues regarding the use of the system, with special emphasis on optical and electrical safety. With proper operation and maintenance, trained and qualified medical practitioners can use the system safely. The supervising physician and all other personnel operating or maintaining the system must be familiar with the safety information provided in this chapter. The primary consideration should be for the safety of the patient, the physician and other personnel. Patient safety is mainly assured by a well-trained staff and a well laid out treatment room. Patient education is also important, including information about the nature of the treatment. 3.1 THE TREATMENT ROOM The treatment room must be clearly labeled with signs indicating that high intensity laser energy is in use. The treatment room sign that is supplied with the system is shown in figure below:

The treatment room should not include any light reflecting objects such as a mirror. 8 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Access to the system treatment room should be allowed only to personnel essential to the procedure and who are well trained in the required safety procedures. Assure that all the treatment room personnel are familiar with the system controls and know how to shut down the system instantly. 3.2 SYSTEM SAFETY MEASURES The system incorporates a number of safety measures to protect the patient and clinician. The following describes those measures. The system has an automatic shutoff if the fiber is removed while firing or the calport is removed during calibration In the startup state, the software performs a Power On Self-Test (POST) to verify all modules are working and system is ready to use. The software monitors the KEY-Switch and transits to the Power-Off state if the KEY-Switch is in the Off position. The software monitors the Emergency-STOP button and transits to the Fault state and turn off laser power if the E-STOP button is pressed. The software monitors the Remote Interlock Switch and transits to the Fault state and turn off laser power if the switch is open. There is an audible alarm to indicate error/fault detection. There is an audible alarm to indication laser emission. The software monitors the communication between SBC and RT Controller, the software will go to the Fault state and turn off laser power if the communication is broken. The hardware watchdog monitors the RT controller software - The RT controller will be reset if the software fails. The software monitors the IR sensor and transits to the Fault state and turn off laser power if the fiber tip flaring is detected. Note: the software will turn off the laser power in the Fault state and Power-Off state. 3.3 ELECTRICAL SAFETY 1. Avoid contact with the ground or with parts that have appreciable capacitance to earth;

2. A semi-automatic circuit breaker protects the system by tripping when power overload occurs;

3. Software Protection 9 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 3.3.1 Light Safety Warning!

Any energy emitting system can cause injury if used improperly. High voltages are present inside the system. Personnel who work with lasers must always be aware of the possible dangers and must take the proper safeguards as described in this manual. Use carefully. May cause serious burns. Precise optical engineering is used to transmit energy to the treatment site. Energy is emitted only through the output ports of the applicators. The system incorporates a safety remote interlock connector for connecting an external interlock on the entrance door to the treatment room. It disables the system and prevents operation when the entrance door is opened. An emergency shutoff knob expedites shutdown when necessary. When pressed, it immediately shuts down system operation. The system features visual and audible emission indicators when laser is firing. 3.3.2 Smoke Evacuation and Laser Plume Pollution Hazards Caution Laser plume, which may contain vaporized tissue particles, pathogens, and toxic gases emanating during laser procedures, is an occupational hazard and may also obscure the operative fields. A commercial smoke evacuator designed for use with surgical medical lasers may be used; these are usually most effective when the plume is extensive. The vacuum tubing or probe used to evacuate the laser plume should not be used to suction blood or fluids unless it is specifically designed and set up to perform both functions simultaneously. Special in-line vacuum systems designed for evacuation of the laser plume may be installed. Flow capabilities should be adequate to effectively remove the laser plume. 3.4 GENERAL PRECAUTIONS AND CAUTIONS The following precautions, cautions, and warning must be observed for the safe use of the system. 3.4.1 Precautions Physicians and clinicians should read this manual thoroughly before attempting to operate the system. 10 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Use of accessories and / or equipment other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation. 3.4.2 Cautions Only InnoVoyce authorized personnel may service the system. This includes making internal adjustments to the power supply, cooling system, fiber, etc. Verify that the system is wired for the appropriate electrical voltage. Maintenance performed by the operator must only take place when the system is shut down and disconnected from the electrical power source. Performing maintenance procedures with the system powered-up can be hazardous to the operator and/or destructive to the system. Ensure proper connection of the fiber before each treatment. Always turn OFF the system when it is not in use. Never leave the system in READY mode unattended. Never allow untrained personnel to operate the system. Never press the applicator's trigger and / or footswitch unless the applicator is safely oriented at a specific and intended target. Never leave the system turned ON, open or unattended during system maintenance. 3.5 THE SYSTEM AND ALL ITS COMPONENTS MUST ALWAYS BE VISUALLY INSPECTED BEFORE TREATING THE PATIENT. IF ANY WEAR OR DAMAGE IS APPARENT, DO NOT USE.WARNINGS RELATED TO ENERGY EMISSION 3.5.1 Burn Hazards The system radiation is invisible to the human eye and can cause third-degree burns, even when unfocused. 3.5.2 Direct and Reflected Eye Exposure Hazards It is essential that all people present in the treatment room during the treatment protect their eyes by wearing InnoVoyce recommended protective eyewear. The protective eyewear must be labeled according to the wavelength and optical density for which they offer protection. It is good practice to instruct the patient (if not anesthetized) to close their eyes during treatment even when wearing protective eye glasses. If the patient cannot wear the protective eyewear, fit the patient with opaque eye protection that completely blocks light from the eyes. 11 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 3.5.3 Laser Safety Eyewear Warning!

Never substitute prescription eyewear for the appropriate laser safety eyewear, as severe eye damage could occur. Prescription eyewear can concentrate the laser light to the eye and / or can be shattered by a high-

power density beam, possibly causing severe eye damage. All personnel must use safety eyewear and should verify that the eyewear provides adequate protection. The safety eyewear and opaque eye protectors are supplied with the system and offer adequate protection. For additional safety eyewear ordering please contact your InnoVoyce representative. Eye protection must have a protection level for 440-465nm with OD 6+ or higher. Absorption of optical energy raises the temperature of the absorbing material. Take precautions to reduce the risk of igniting combustible materials in and around the treatment area. Have water available to extinguish small fires. The system is not suitable for use in the presence of flammable mixtures with air or oxygen. Do not operate in the presence of volatile solvents such as alcohol, gasoline or other solvents. Do not use any flammable substances such as alcohol or acetone in the preparation of the skin for treatment. If necessary, use soap and water to clean before treatment. If alcohol is used to clean any part of the system, allow it to dry thoroughly before operating the system. See Maintenance section below for proper cleaning instructions. Flammable substances must be kept at a safe distance from the system. During treatment also pay attention to the possible danger of ignition of endogenous gases. Nominal Ocular Distances NOHD for Main beam with OD 8 safety glasses 4.74 meters for main beam Main beam diffuse reflection 61.2cm 6.12cm for aiming beam 0.0474 cm 12 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 3.5.4 High Voltage Hazards Warning!

The electrical cable should be removed from wall electrical outlet before any service or in case of any detected malfunction. The system utilizes high-voltage electricity. To avoid personnel injury, do not operate the system before ensuring that the exterior panels are undamaged and properly closed. Do not attempt to remove or disassemble the exterior panels. The system produces very high voltages in various components. Some components may retain a charge after the power supply has been turned OFF. No part of the exterior housing should be removed, except by InnoVoyce authorized personnel. Never leave the system turned ON, open or unattended during system maintenance. To avoid personnel injury, do not operate the system before ensuring that the exterior panels are properly closed. Do not attempt to remove or disassemble the exterior panels. 3.5.5 Grounding the System The system is grounded through the grounding conductor in the power cable and internal grounding pin. Warning!

To avoid the risk of electric shock, this equipment must only be connected to a grounded power outlet. 3.6 SYSTEM SAFETY FEATURES The system is equipped with various safety features. All treatment room personnel should be familiar with the location and operation of these safety features. The detailed information provided in CHAPTER 3 System Description:

Emergency Shut-off Knob Emissions Indicators Footswitch Circuit Breaker Remote Interlock Key Lock 13 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 3.7 SYSTEM AND EQUIPMENT CLASSIFICATIONS AND COMPLIANCE Equipment is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. CDRH Laser Classification according to 21CFR 1040.10:

Laser Classification according to EN 60825-1:

Class IV Class 4 Light Source Classification according to IEC60101-2-57:

Risk Group 3 Aiming Beam Class Mode of Protection against Electric Shock:

Class 3R Class I Equipment Degree of Protection against Electric Shock:

Type BF Applied Part Not suitable for use in presence of flammable anesthetic mixture with air or nitrous oxide. 3.8 LABELING AND SIGNS The following labels are adhered to the system:

14 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Identification/System Label Eye Safety Filter Label Laser Danger Class IV warning and information label. 15 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Grounded power cable warning label Electrical Requirement and Hazard label Laser aperture warning label

(aperture at distal end of attachment) Laser radiation warning label Emergency Stop label located below the emergency shut-off knob Interlock port label Optical fibre applicator Footswitch port label Packaging label Prescription Only 16 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Sterile / ETO for fiber Waste Electrical and Electronic Equipment Manufacturer Manufactuer date Catalog number Serial number Applied Part Type BF Lot Number Manual Reference Radiofrequency warning Direct Current 17 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 3.9 CONTRAINDICATIONS The laser system should only be used in conditions where its use is appropriate and of proven efficacy. Clinical applications should be performed by a qualified surgeon. The use of the laser is contraindicated for patients:

Whose general medical condition contraindicates surgical intervention. Where appropriate anesthesia is contraindicated by patient history. Where tissue (especially tumors) has calcified. For hemostasis of vessels over approximately two millimeters in diameter. Where laser therapy is not considered the treatment of choice. 4 SYSTEM DESCRIPTION This chapter provides a detailed description of the system. The description covers the systems main components, controls, and system specifications. 4.1 GENERAL SYSTEM DESCRIPTION The InnoVoyce Surgical Laser is a solid-state laser device in which laser energy is generated by internal diodes. The laser output energy of the device is in the surgical spectrum at a 440-

450nm wavelength. The output settings of the laser can be adjusted by the user. The InnoVoyce Surgical Laser consists of a console with a graphical touch screen user interface, a footswitch, and single-use, disposable fibers. The system has four laser emission modes: Continuous Wave

(CW), Pulsed Wave (PW), Quasi Pulsed Wave (QPW), and Quasi Continuous Wave (QCW). InnoVoyce Fibers are sterile, single use, disposable laser delivery devices designed to deliver laser energy with the InnoVoyce Surgical Laser. Fibers are available in diameters of 300, 400, and 600 microns. 4.2 System Specifications The system shall operate with fibers according to the General operating parameters as shown in the table below. 18 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 System Specifications Light Source Applied Part Wavelength Max Output Power Divergence from Fiber Aiming Beam Wavelength Aiming Beam Max Output Power Diode Laser Fiber 450nm 10nm 30W 3W 15 3 515nm 5mW Fiber Sizes 300m, 400m and 600m Nominal Ocular Distances Operating Temperature/Humidity requirements Operating Atmospheric Pressure Storage Temperature/Humidity Requirements Weight Dimensions Power Requirements Size of fixed earthing conductor (lug) Composition of coolant 15C - 30C (59F - 86F) / <95%

The device is not approved for operation at altitudes above 2000 m (SL) and for an air pressure between 1080 hPa and 750 hPa 0C - 40C (32F - 104F) / <95%

20.5kg 13.4 x 14.7 x 14 100VAC to 240VAC +/- 10%

0 to 5A 50Hz to 60Hz 6mm 1,2-propanediol, water, Methyl-1H-

Benzotriazole, Sodium benzoate 19 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Operating Parameters 4.3 SYSTEM COMPONENTS AND CONTROLS 4.3.1 Control Panel The system control Panel incorporates the following:

Fiber Holder Calibration Port and fiber installation Figure 1 Front of Console 20 Display Emergency shutoff Key Switch InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 4.3.2 Display The InnoVoyce system is controlled by a user friendly display where users can access system features and functions by touching the appropriate buttons on the screen. The screen is password protected. 4.3.3 Laser Fiber The laser fiber is provided sterile and is single-use, except in the following special circumstances:

The fiber has been assigned for use with the specified system The last fiber used by the system is the same fiber The previous treatment was not completed The system was power cycled as a result of a hard fault that has been resolved The fiber is reconnected to the system within a specified time after first use The fiber has emitted energy for less than a specified time limit The fiber has tried to reconnect no more than a specified number of times Store the laser fiber in a clean environment. If the sterile pouch has been compromised in any way, dispose of the fiber and do not use for treatment. For single patient use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse, reprocessing or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-

infection, including, but not limited to, the transmission of infectious disease(s)from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient. After use, dispose of product and packaging in accordance with hospital, administrative and / or local government policy. Figure 2: Laser Fiber in packaging 21 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 4.3.4 Microscope filter The microscope filter enables the laser to be used in conjunction with operating room microscopes and provides eye protection to the surgeon. The device connects to the laser with an electrical cable on the rear of the console (see figure XX below). The system software allows the operator to select whether the microscope filter will be used during treatment. Bottom Top 4.3.5 Cooling System The InnoVoyce Surgical Laser systems includes internal coolant that will not degrade in performance over the expected shelf life of the device. 4.3.6 Emergency Shut-Off The emergency shut-off is a red knob on the front of the system console. When pressed it immediately shuts off the systems power. 4.3.7 Emission Indicators To indicate that the laser is being fired, the laser ready button on the display turns from green to red and there is an audible beep when the foot pedal is depressed. 22 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 4.3.8 Rear Panel 4.3.9 Main Power Switch The main power switch is located on the rear of the console. See image XX above. 4.3.10 Footswitch Laser emission is controlled by the user through the operation of a wired foot switch. The footswitch is connected to the device at a port on the rear of the console. See image xx above. 23 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Footswitch Image 4.3.11 Remote Interlock The system incorporates a safety remote interlock connector that connects an external interlock on the entrance door to the treatment room. The interlock disables the system and prevents operation when the treatment room door is opened. The remote interlock is connected to a port on the rear of the console. See image XX above. 5 INSTALLATION NOTE: Any damage to the packaging or system found prior to opening the package should be reported to InnoVoyce. The system is designed for installation in a surgical and clinical environment. A technician from InnoVoyce is required to perform the on-site installation. 5.1 EQUIPMENT LIST 1 x Laser Console 1 x Foot Switch 1 x Power Cord International, 12 feet Length 2 x Physician Laser Safety Goggles 6 x Supporting Laser Safety Goggles 1 x Instructions for Use, English 2 x Laser Safety Sign, English 24 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 1 x Remote Interlock connector, shorted 1 x Microscope Filter (Leica) 1 x Microscope Filter (Zeiss) 5.2 FACILITY REQUIREMENTS Before unpacking the system, ensure that the site meets the requirements described in the following sections. 5.2.1 Electrical requirements Caution The system should be connected to a separate power line with a separate circuit breaker. InnoVoyce cannot guarantee the performance of the device unless it is connected to a dedicated circuit. The system power line should not be shared with other heavy variable loads such as elevators, air conditioning systems, large motors, etc. The system is grounded through the grounding conductor in the power cable that is plugged into the wall power outlet. Good grounding is essential for safe operation. Environmental Requirements 5.2.2 Are there any specific environmental requirements? (Temp and humiditiy, space and positioning of the device, etc?) 5.3 UNPACKING THE SYSTEM 25 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 5.4 MOVING THE SYSTEM The Innovoyce Surgical Laser is a compact system that can be moved easily. The system console comes equipped with handles on the front and back that can be used to pick up the console. An optional cart can also be used to move the system. To move the InnoVoyce Surgical Laser within the clinic:

1. Ensure the System is completely shutdown and the mains AC power switch is in the off position. 2. Disconnect the power cable. 3. 4. Slowly push or pull the InnoVoyce Surgical Laser, using the handlebar on the cart to the desired If using the cart, ensure the caster wheels are unlocked. location. Do not use the cart handlebar to lift the System off the floor. 5. If moving without the cart, ensure cable and accessories are properly stored or removed, and lift the system by the handles on the front and back of the console. 6 OPERATING INSTRUCTIONS This chapter describes the operating instructions for the system. Specific treatment parameters and clinical guidance are provided separately. 6.1 CONNECTING THE SYSTEM 1. Confirm the system is in the off position. 2. Find the power cord for the system. Plug one end into the power connector on the rear panel of the system, and the other end into a grounded outlet. 3. Ensure cooling system vents are not blocked. 4. Ensure console is place in a location that does not block access to disconnecting the device (plug or appliance inlet). 6.2 ATTACHING THE MICROSCOPE FILTER 1. Attach the microscope filter cable to the port on the rear panel of the console (see image xx above). 2. When the system is turned on, the operated will be prompted to select whether the microscope filter is used during treatment. 6.3 REMOTE INTERLOCK AND FOOTSWITCH CONNECTION 1. Attach the Remote Interlock and footswitch cables to the appropriate port on the rear panel of the console (see image XX above). 26 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 6.4 OPERATING THE SYSTEM 6.4.1 Turning ON the System 1. Turn the Keyswitch ON 2. Flip the AC power switch on the back of the device. 3. The control panel will display the following image when the system is turned on:

System Calibration 6.4.2 When the system start-up has completed, the system will conduct a calibration to ensure the device is transmitting the correct power. In order for the calibration to occur, the fiber must not be installed and the fiber port cover must be closed. When calibration port is closed, the start button turns to a solid blue . Press Start to initialize the calibration process. 27 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 The calibration process is an automated routine that runs each time the device is powered on to test the laser output and calibrate the system for proper treatment levels. The calibration process can also be initiated anytime by the user when the system is in standby state. If the calibration is a success, the system will display a message and allow the user to proceed to the treatment screen. However, if calibration is outside of acceptable range, then the system will prompt the user to recalibrate the system. The user may try up to five (5) time to recalibrate before the system will generate a fault and will become inoperable until a repair can be performed. System message for successful calibration System message for calibration error 6.4.3 Microscope Filter selection Once calibration has succeeded, a popup window will appear to select if the microscope filter will be used by the system during treatment. If the microscope filter is to be used, the system will move the microscope filter into position during the laser emission state. The device will not fire until it senses that the microscope filter has been connected. 28 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Installing the laser fiber 6.4.4 After the microscope filter has been moved into place (if selected), the system will display the standby screen (see image XX below) and the laser fiber can be installed into the calibration port. Open the calibration port and place the handle end of the fiber into the calibration port, and turn clockwise to secure it in place. The following images show the installation of the fiber. Orientation of fiber for installation Fiber installation After installing the fiber, the system will conduct a fiber authentication to ensure a new fiber was installed. 29 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Standby screen before fiber installation Standby screen with solid blue Ready button after fiber installation After authentication, treatment parameters can be selected prior to firing the laser. Caution when inserting, sharply bending, or improperly securing the fiber beam delivery and electrical harness. Failure to follow the instructions may lead to damage to the fiber beam delivery and may lead to harm to the patient or LASER OPERATOR due to fiber break and/or miss-alignment of the optics components. 6.5 TREATMENT MODES AND PARAMETERS The Standby state allows the user to select the desired laser operation mode as well as the various control parameters associated with each laser operational mode. The follow image is the display screen in Standby mode with adjustable parameters identified below. 30 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 6.5.1 Pulsed The pulsed mode will cause the laser to emit discrete bursts of energy. In pulse mode, the user can adjust:

Laser Power Output Peak power the laser emits measured in Watts (W) Laser Pulse Duration Amount of time the pulse is ON measured in milliseconds (ms) Pulse Per Second (p/s) Number of pulses in a second. This ranges from 1 pulse up to a maximum of 10 pulses per second. Shot Limit Count Maximum number of times the laser emits each time the footswitch is pressed. This can be set at either 1-10 or No Limit. Total Energy Delivered (J) Summed total of all energy emitted during the treatment. Figure 3 Treatment mode: Pulsed 6.5.2 Quasi-Pulsed The quasi-pulse mode will cause the laser to emit energy in the form of macro pulses consisting of micro pulses. In quasi pulse mode, the user can adjust:

Laser Power Output Peak power the laser emits measured in Watts (W) Laser Macro Pulse Duration Amount of time the pulse is ON measured in milliseconds

(ms) Laser Micro Pulse Duration Amount of time the pulse is ON measured in milliseconds

(ms) Pulse Per Second (p/s) Number of pulses (macro) in a second. This ranges from 1 pulse up to a maximum of 10 pulses per second. Shot Limit Count Maximum number of times the laser emits each time the footswitch is pressed. This can be set at either 1-10 or No Limit. 31 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Total Energy Delivered (J) Summed total of all energy emitted during the treatment. Figure 4 Treatment Mode: Quasi-pulsed 6.5.3 Continuous The continuous wave mode will cause the laser to emit laser power continuously without any modulation of power output. In continuous wave mode, the following can be adjusted:

Power Output Average power the laser emits measured in Watts (W) Treatment Timer Amount of time the laser can emit laser power measured in minutes

(min) and seconds (s) Total Energy Delivered (J) Summed total of all energy emitted during the treatment. Figure 5 Treatment Mode: Continuous 32 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 6.5.4 Quasi Continuous The quasi continuous wave mode will cause the laser to emit laser power continuously without any modulation of power output. In continuous wave mode, the following can be adjusted:

Power Output Average power the laser emits measured in Watts (W) Treatment Timer Amount of time the laser can emit laser power measured in minutes

(min) and seconds (s) Pulse Per Second (p/s) Number of pulses in a second. This ranges from 1 pulse up to a maximum of 1 kHz. Duty Cyle The ratio of time the laser is delivering energy. Total Energy Delivered (J) Summed total of all energy emitted during the treatment. Note!

The treatment does not have to be in a single pulse. Laser emission can be interrupted any time by lifting up on the foot switch. This will not interrupt the treatment time remaining timer. Note!

If the continuous output power is 20W or higher, the system will impose a max emission time of 20sec per foot petal press. 6.5.5 Aiming Beam In the Standby state, the operation of the aiming beam can be adjusted as follows:

Always On The aiming beam will be ON at all times Laser Emission and Laser Ready The aiming beam will automatically turn ON when the system is in the Laser Ready and Laser Emission states. The aiming beam will be OFF at all other times. 33 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Laser Emission Only The aiming beam will automatically turn ON only in the Laser Emission state. The aiming beam will be OFF at all other times. Always Off The aiming beam will be OFF at all times The aiming beams intensity can be adjusted to be:

0% - The aiming beam intensity is set to 0% nominal output brightness 25% - The aiming beam intensity is set to 25% nominal output brightness 50% - The aiming beam intensity is set to 50% nominal output brightness 75% - The aiming beam intensity is set to 75% nominal output brightness 100% - The aiming beam intensity is set to 100% nominal output brightness Note!

The aiming beam will be automatically set to 0% intensity if the aiming beam mode is set to be always off. Firing the Laser 6.5.6 When the correct treatment parameters have been selected, pressing the READY button at the bottom of the screen will enable the laser to be fired. There is a 2 second delay with a beep when the device transitions from Standby to Laser Ready. The top left corner of the screen will display Laser Ready and show that the footswitch can be depressed to fire the laser. Press the Ready button to enable treatment Indicator that laser is ready to fire Note!

When the laser is in ready mode, only the aiming beam can be adjusted. To fire the laser, depress the foot pedal. The system will make an audible sound while the laser is firing and the below image will be displayed. 34 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Warning!

All personnel, including patient, should wear appropriate eye protection. Fiber Tip Flare 6.5.7 The system is designed to detect when there is a fiber tip flare during use. When a flare occurs, the following error screen will display. Complete instructions for cleaving the fiber and fiber maintenance during surgery can be found in the Laser Fiber Instructions For Use. After cleaving the fiber, press Continue and the device will return to Standby. 6.5.8 Returning to Standby When the footswitch is released, the system will return to Laser Ready screen. 35 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 Return to Standby by pressing the Standby button or anywhere on the screen except the aiming beam parameters. Those parameters can still be adjusted in the Laser Ready state. If the system is idle for 3 minutes, it will automatically return to the Standby screen. Shutting off the System 6.5.9 The system can be disconnected by unplugging the power cord from the wall socket. 6.6 TREATMENT CONSIDERATIONS The InnoVoyce Surgical Laser is a surgical device that should be used only by physicians or sur-

geons who have been trained in laser surgery through courses, preceptorships, and under the guidance of other physicians or surgeons knowledgeable in laser use. No claim is made that the laser will cure any medical condition. BEFORE operating the laser system, surgeons and all staff operating the laser should carefully read this manual. Surgeons using the InnoVoyce Surgical Laser must understand the lasers unique proper-

ties prior to using the device. Prior to turning the laser system on, operating room personnel and the patient should be wearing protective eyewear suitable for laser energy. Careful assessment of the target and surrounding tissue should be made, and appropri-

ate power and pulse duration should always be used. Tissue perforation can result if excessive laser energy is applied. This can occur through the use of excessive laser power or the application of power for excessive periods of time, particularly in diseased tissue. Aim and use the laser only on tissues that are in full view. Extra caution should be used when lasing tissue close to known arteries, nerves and veins. Begin laser treatment at the lowest power, with short duration exposures until fully fa-

miliar with the tissue effects of the applicable wavelength. Patients who experience discomfort during laser treatment may require analgesics. As with conventional non-laser surgical procedures, there is no guarantee that treat-

ment with the InnoVoyce Surgical Laser will entirely eliminate the diseased entity. Re-

peated treatment or alternative therapies may subsequently be required. The laser may not be effective for coagulation in massive hemorrhage situations. The surgeon must be prepared to control hemorrhages with strident alternative non-laser techniques, such as ligature or cautery. Alterations in surgical approach or technique may be required to accommodate laser use. 36 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 The surgeon should schedule follow-up visits in the same manner as for any patient un-

dergoing such surgery with other modalities. A smoke evacuator and in-line filter should be used to capture the smoke plume that re-

sults from laser procedures. The plume should be regarded as a source of active biologi-

cal material and a possible carcinogen. 7 MAINTENANCE AND CLEANING 7.1 MAINTENANCE AND CLEANING This chapter contains maintenance and cleaning instructions for the system. Warning!

Unauthorized servicing or modification of this system not described in this manual may expose the operator or patient to potential high voltage and laser radiation hazards. Improper use or adjustment of this system may invalidate the service warranty agreement. The system generates high voltages and laser radiation when powered up. Maintenance should be performed only when the system is shut down and the power cable disconnected from the mains power source. Performing maintenance procedures with the system turned on may be hazardous to the operator and/or destructive to the system. Routine maintenance may be performed by clinic staff unless otherwise specified. Any maintenance procedure not mentioned in this chapter must be performed only by an InnoVoyce authorized technician. 7.2 CLEANING Laser Fiber 7.2.1 The laser fiber is provided sterile and is intended for single-use. The laser fiber should be discarded after every patient or if damaged during use. External Surfaces 7.2.2 External surfaces of reusable system components shall withstand wipe down without loss or degradation of performance or appearance with 70% Isopropyl Alcohol Solution. The operator should periodically wipe the outside surfaces of the laser with a cloth dampened with 70%

Isopropyl Alcohol. Stubborn marks can be removed with a cleaning cloth dampened with a weak 37 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 solution of water and mild detergent or a cleaning agent. Never use harsh or abrasive cleaners or pour water onto the device. 7.3 PERIODIC SERVICE The system should be periodically inspected and maintained to keep it in peak operating condition. The routine service operations should be performed by an InnoVoyce authorized technician. If periodic service is not performed according to schedule by an InnoVoyce-authorized service provider, any warranty agreement of the system and its associated applicators and/or accessories will be invalidated. During periodic service, the system's protective panels must be opened. Therefore, this is performed only by InnoVoyce service personnel. A recommended routine inspection and maintenance schedule:

Inspection/Service Frequency Inspected by:

7.4 SERVICE INFORMATION In communications with InnoVoyce authorized representatives, always include the part number and serial number indicated on the systems label. Questions or problems should be referred to:

InnoVoyce Customer Service

(617) 865-9401 8 TROUBLE SHOOTING 38 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 8.1 SYSTEM FAULTS The following tables list the hard and soft system faults. Soft faults turn the laser power off, while hard faults require the software to power cycle the system in order to recover. TABLE NUMBER: Soft Faults Sr. No. Error Data Name Error Details 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 Fault 1 Fault 2 Fault 3 Fault 4 Fault 5 Fault 6 Fault 7 Fault 8 Fault 9 Fault 10 Fault 11 Fault 12 Fault 13 Fault 14 Software checksum mismatched POST message failed Microscope filter disconnected Microscope filter is not in the field of view Calibration process failed Calibration process canceled Fiber disconnected Fiber used previously System input voltage is out of acceptable range Power rail voltage is out of acceptable range to power up laser module Power rail voltage is out of acceptable range to power up SBC module Real time laser-emission comparison mismatched Calibration detector comparison mismatched Communication interruption between SBC & RT Controller Fault 15 Emergency stop button pressed Fault 16 . Fault 24 FUTURE USE TABLE NUMBER: Hard Faults Sr. No. Error Data Name Error Details 39 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 1 2 3 4 5 6 7 8 Fault 25 Fault 26 Fault 27 Fault 28 Fault 29 Fault 30 Fault 31 Fault 32 Calibration process failed for 5 times in a row Laser diode temperature is less than or equal to 14 degrees Celsius Laser diode temperature is greater than or equal to 44 degrees Celsius Cooling liquid temperature is less than or equal to 14 degrees Celsius Cooling liquid temperature is greater than or equal to 44 degrees Celsius Microscope filter is not in the correct position Communication broken between SBC & RT Controller 9 ELECTROMAGNETIC COMPATIBILITY FORTHCOMING FCC Compliance FCC ID: 2BDH3ASY300056 Changes or modifications not expressly approved by InnoVoyce could void the user's authority to operate the equipment. This device complies with Part 15 of 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. Note: This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 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 communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. 40 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 10 ESSENTIAL PERFORMANCE 1. Power output Display value should be +/- 20% emission in all modes (Continuous, Pulsed, QCW, QP)

(See Matrix). 2. E Stop function Emergency Stop button must stop laser power. 11 DISPOSAL OF DEVICE At the end of the useful life the system and its accessories should be returned to the manufacturer for appropriate processing and disposal. 41 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 APPENDIX A: PRE-TREATMENT PREPARATIONS The following steps should be taken to ensure favorable treatment conditions. Determine if the patient can be treated and has no contraindications for treatment. o Whose general medical condition contraindicates surgical intervention. o Where appropriate anesthesia is contraindicated by patient history. o Where tissue (especially tumors) has calcified. o For hemostasis of vessels over approximately two millimeters in diameter. o Where laser therapy is not considered the treatment of choice. Determine why the patient is seeking treatment and what his/her expectations are. Complete or update the patient's medical and physical history. Inform the patient about the treatment protocol, typical treatment results and possible adverse effects and discomfort. Advise the patient about pre- and post-treatment care instructions. Instruct the patient about the safety issues of the treatment Treatments may be performed according to the treatment mode used. Treatment should conform to all laser safety instructions and should be conducted according to the following guidelines:

Dedicated eye protection must be worn during treatment by both the patient and staff. Care must be taken to avoid unintended exposure of the treatment beam to the pa-

tient's eyes or non-target tissue. Such exposure can cause possible damage. Once the laser operating parameters have been selected and the handpiece positioned at the proper treatment area, press the footswitch to activate the laser treatment. 42 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023 APPENDIX B: POST TREATMENT LOG SHEET Date:

Patient:________ Laser Certified Surgeon(s):________________________________________________________ Assistant: _____________________________________________________________________ Eye Protection: Patient:__________ Staff:_______________ Windows Covered:

Warning Signs:

YES/NO YES/NO Fire Safety Measures:

YES/NO LASER Protocol Followed:

YES/NO Procedure done for:_____________________________________________________________ Fiber Size:

300pm 400pm 600pm Power Setting (Watts):__________ Mode: ____________________ Pulse Duration (msec):__________ Repetition Rate (pps):________ Total energy output from laser (joules):______________________________ Total time on tissue:_____________________________________________ 43 InnoVoyce Surgical Laser User Manual Draft 002 - October , 2023

***Total energy output from laser may not represent total energy delivered to the patient. Comments:

44

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6972238.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case ID LABEL

(sample for FCC purposes only) Label Location

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6972236.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case OFFICAL AUTHORIZATION LETTER 10/5/2023 To Whom It May Concern:

We hereby delegate CKC Certification Services, LLC (CKC CS) power of attorney to act on our behalf in matters pertaining to certification of products. The actions of CKC CS shall be considered the same as our own. Sincerely, Stephen Mais Director of Operations InnoVoyce LLC. One Beacon St Floor 15 Boston, MA 02108 05 OCT 2023

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6972237.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case 11/9/2023 Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Subject: Request for Permanent Confidentiality To whom it may concern:

In accordance with 47CFR Section 0.457 and Section 0.459 pertaining to confidential material, we hereby request to hold permanently confidential all information contained within the below identified exhibits/document categories submitted pursuant to radio equipment certification requirements for FCC ID: 2BDH3ASY300056 1. Block Diagram 2. Operational Description 3. Schematics The above material contains trade secrets and proprietary information as specified by 47CFR 0.457(d) and technical data, which would customarily be guarded from competitors. The public disclosure of this information might be harmful to our company and provide unjustified benefits to our competitors. Sincerely, Stephen Mais Director of Operations InnoVoyce LLC 09 NOV 2023

WARNING:pdfminer.pdfpage:The PDF <_io.BufferedReader name='/Volumes/Scratch/Incoming/eg-scratch/6972233.pdf'> contains a metadata field indicating that it should not allow text extraction. Ignoring this field and proceeding. Use the check_extractable if you want to raise an error in this case CKC Certification Services, LLC CB: US0103; NB/AB: 0976 5046 Sierra Pines Drive Mariposa, CA 95338 Phone: 1 800-500-4EMC (4362) Fax: 209-787-5568 Email: tcbadmin@ckc.com Applicant Information Company Name:

Contact Name:

Contact Title:

Company Address:

Telephone No:

Facsimile No:

Email Address:

APP-FCC-A Applicant Attestation InnoVoyce LLC Stephen Mais Director of Operations One Beacon St Floor 15 Boston, MA 02108

(203) 417-6140 Stephen.mais@innovoyce.com Certification Type / Equipment Identification Certification Program:

Certification Number:

FCC Equipment Authorization / Radio Certification 2BDH3ASY300056 The equipment identified above is / is not covered equipment prohibited from receiving an equipment authorization pursuant to 47 CFR Part 2, Subpart J, 2.903. The applicant identified above is / is not identified on the FCCs Covered List as an entity, affiliate, or subsidiary which produces equipment on the Covered List or identified as an entity which has rebranded or relabeled equipment produced by entities identified on the Covered List. I hereby attest and certify that the above statements are true and correct. Signature of Authorized Individual: 1 Printed Name:

Title of authorized signature:

Date Stephen Mais Director of Operations 11/9/2023 Note this attestation shall be signed by the applicant or their direct appointee within the same legal entity. A third party agent is not permitted to sign on behalf of the applicant. 1 Signature is not subject to the FCCs authorized individual policy (KDB 852134) and may be signed by any appropriate company official. APP-FCC-A Page 1 of 2 Rev 3 CKC Certification Services, LLC CB: US0103; NB/AB: 0976 5046 Sierra Pines Drive Mariposa, CA 95338 Phone: 1 800-500-4EMC (4362) Fax: 209-787-5568 Email: tcbadmin@ckc.com Attachment A Additional Information The FCCs Covered List includes certain telecommunications equipment and video surveillance equipment produced by specific manufacturers, their Affiliates or Subsidiaries and including any products produced by these entities which are rebranded or relabeled by other entities. (191, 184, 185, 188) 2 The FCC claims the identified equipment poses an unacceptable risk to United States national security. Telecommunications Equipment (195):

Any equipment used in fixed or mobile networks that provides advanced communications service, provided the equipment includes or uses electronic components, as defined under section 1.50001(c). Video Surveillance Equipment (205):

Any equipment that is used in fixed and mobile networks that provides advanced communications service in the form of a video surveillance service, provided the equipment includes or uses electronic components. Advanced Communications Service (195, 205) Any equipment that can be used in such a fixed or mobile broadband network to enable users to originate and receive high quality voice, data, graphics, and video telecommunications service using any technology with connection speeds of at least 200 kbps in either direction. Affiliate (183):

An entity that (directly or indirectly) owns or controls, is owned or controlled by, or is under common ownership or control with, another entity, where the term own means to have, possess, or otherwise control an equity interest (or the equivalent thereof) of more than 10 percent. Subsidiary (184):

Any entity in which such named entity directly or indirectly (1) holds de facto control or (2) owns or controls more than 50% of the total voting power of the entitys outstanding voting stock. Useful Links:

FCC Covered List https://www.fcc.gov/supplychain/coveredlist 47 CFR Part 2 Subpart J (including 2.903 and 2.911) https://www.ecfr.gov/current/title-47/chapter-I/subchapter-A/part-2/subpart-J FCC KDB System:

https://apps.fcc.gov/oetcf/kdb/index.cfm FCC Report and Order 22-84 https://docs.fcc.gov/public/attachments/FCC-22-84A1.pdf 2 Parenthetical references are citations of paragraph numbers in FCC Report and Order FCC 22-84 (ET Docket 21.232). APP-FCC-A Page 2 of 2 Rev 3

Attestation For United States Agent for Service of Process Self-Designation for US Based Manufacturers Only Applicant / Equipment Manufacturer Information Company Name:

Grantee Code:

FRN:

Stephen Mais 2BDH3 0034450502 Applicant Attestation The undersigned hereby consents:

a) b) c) d) to self-designation as US Agent for Service of Process; and to accept responsibility and obligation to maintain self-designation for no less than one year after either all marketing and importation of the applicable equipment within the U.S has been permanently terminated, or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later; and to accept service of process in the US for matters related to the applicable equipment and at the physical address and email address identified in the applicants grantee code registration for equipment authorization applications under certification pursuant to 47 CFR Part 2 Subpart J; and to maintain current grantee code information on file in accordance with 47 CFR Part 2.929. Signature of Applicant:

Printed Name:

Date:

Stephen Mais 11/9/2023 CKC CS PUB FCC AFSOP Self Designation v4