FCC ID: 2AYGA2032 CUBE

Pain Therapy NeuroBlock Spinal Cord Stimulation System NeuroBlock Models 1001, 1401, 2032 1001, 1401, 2032 User Manual Rx only 2021-Feb Label Symbols Explanation of symbols on products and packaging. Refer to the appropriate product for symbols that apply. Consult instructions for use Temperature limitation Use by Manufacturer Do not dispose of this product in the unsorted municipal waste stream. Dispose of this product according to local regulations. Magnetic Resonance (MR) Unsafe. Serial number Keep dry IEC60601-1/EN60601-1, Type BF equipment Non-ionizing electromagnetic radiation Authorized Representative in the European Community GIMER Medical is a trademark of GiMER Medical Co. Ltd., registered in the U.S. and other countries. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by GiMER Medical is under license. FCC Information The following is communications regulation information on the Model 1001 External Stimulator. 2021-Feb M203210201V1.3 English 1 i xx xx xx xx N FCC ID:

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. 2 English M203210201V1.3 2021-Feb Table of Contents Label Symbols ........................................................................... 1 2 Table of Contents ...................................................................... 3 1 INTRODUCTION ................................................................... 5 How to use this manual ......................................................... 5 Patient Identification Card ...................................................... 6 IMPORTANT THERAPY INFORMATION............................. 7 Purpose of the device ............................................................ 7 Purpose of the spinal cord stimulation (SCS) system

(indications) ........................................................................... 7 Description of your system .................................................... 7 Therapies that may not be used with the SCS system

(contraindications) ................................................................. 9 Risks and benefits ................................................................. 9 Risks of surgery ..................................................................... 9 General Warnings .................................................................. 9 Precautions .......................................................................... 13 Individualization of treatment ............................................... 15 3 RECOVERY AND CARE AFTER SURGERY ..................... 16 Recovery from surgery ........................................................ 16 Activities .............................................................................. 16 When to call your clinician ................................................... 17 Care schedule ...................................................................... 17 4 USING YOUR CUBE .......................................................... 18 How your Cube works .......................................................... 18 Cube function keys and indicators ....................................... 19 Turn on and off the Cube ..................................................... 23 Cube power status ............................................................... 24 Recharging Cube ................................................................. 25 Reboot the Cube .................................................................. 26 5 USING CUBE TO START STIMULATION DURING TRIAL PHASE ................................................................................ 27 6 USING CUBE TO START STIMULATION DURING PERMANENT IMPLANTATION PHASE ............................ 31 7 TROUBLESHOOTING ........................................................ 37 8 ADDITIONAL INFORMATION ............................................ 40 Adverse events .................................................................... 40 2021-Feb M203210201V1.3 English 3 Possible system complications ............................................ 41 9 MAINTAINENCE AND ASSISTANCE ................................ 42 Cleaning and care ................................................................ 42 Safety and technical checks ................................................. 42 Battery, Cube, and External Stimulator disposal .................. 42 Implantable Receiver disposal ............................................. 42 Specifications ....................................................................... 43 User assistance ................................................................... 44 4 English M203210201V1.3 2021-Feb 1 INTRODUCTION How to use this manual Use this manual during trial phase and after receiving an Implantable Receiver. Ask your clinician to explain anything that is unclear.

"1 INTRODUCTION", describes how to use this manual and information about the patient identification card.

"2 IMPORTANT THERAPY INFORMATION", describes when you should and should not use a spinal cord stimulation system, the spinal cord stimulation system components, and the risks, benefits, warnings, precautions, and patient activities related to your spinal cord stimulation system.

"3 RECOVERY AND CARE AFTER SURGERY", provides information about recovering from surgery, activity and care information, and when to contact your clinician.

"4 USING YOUR CUBE", DESCRIBES THE CUBE, how to control and recharge the Cube.

"5 USING CUBE TO START STIMULATION DURING TRIAL PHASE", describes how to adjust your stimulation using your Cube during trial phase.

"6 USING CUBE TO START STIMULATION DURING PERMANENT IMPLANTATION PHASE", describes how to adjust your stimulation using your Cube during permanent implantation phase.

"7 TROUBLESHOOTING", describes Cube warning, alert, and how to solve problems.

"8 ADDITIONAL INFORMATION", describes how stimulation works, possible adverse effects, changes in therapy, and possible system complications. 9 MAINTENANCE AND ASSISTANCE describes how to care for your Cube, and instructions on using accessories. This chapter also provides Cube specifications and information about who to call for assistance. 2021-Feb M203210201V1.3 English 5 Patient Identification Card A temporary patient identification card will be provided to you at the hospital during Trial Phase. This card supplies information about you, your implanted device, and your doctor. Your identification card may allow you to bypass security devices. If you move, change doctors, or lose your card, contact GiMER Medical for a replacement card. Refer to the GiMER Medical contacts at the end of this manual. After GiMER Medical receives your implant registration from the hospital, you will receive a permanent identification card. 6 English M203210201V1.3 2021-Feb 2 IMPORTANT THERAPY INFORMATION Purpose of the device Cube (Model 2032) is designed to control the following components of GiMER Medical NeuroBlock SCS System:

External Stimulator (Model 1001) Implantable Receiver (Model 1401) Purpose of the spinal cord stimulation (SCS) system

(indications) The GiMER Medical NeuroBlock SCS System is indicated as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic, intractable pain of the trunk and/or lower limbs, including unilateral or bilateral pain. Description of your system A GiMER NeuroBlock SCS system has implanted parts that deliver the electrical pulses to block your pain signals. GiMER NeuroBlock SCS system (Figure 1) includes: a Cube (an external controller, for controlling your system), an External Stimulator (ES), an Implantable Receiver

(Receiver), and two lead kits (Medtronic, Vectris SureScan MRI 1x8 Compact 977A260). 2021-Feb M203210201V1.3 English 7 Figure 1. Schematic View of NeuroBlock SCS System Note: This manual provides instructions for using the Cube only. For instructions about the External Stimulator and the implantable components, e.g., lead kit and the Implantable Receiver, the related manuals will be provided to the clinician. 1. Cube (Model 2032) A hand-held controlling device that you use to, view, select, adjust, and control your stimulation. Refer to USING YOUR CUBE on page 18 for more information. 2. External Stimulator (ES) (Model 1001) A disposable, single-use device delivers stimulation through leads. During trial phase, the External Stimulator is used to evaluate whether the GiMER NeuroBlock SCS System effectively relieves pain, prior to implantation of the permanent components of the NeuroBlock SCS System. 3. Implantable Receiver (RS) (Model 1401) The permanent implanted component of the GiMER NeuroBlock SCS System. During treatment, the Implantable Receiver receives the control signals of stimulation and power from the Cube in order to generate stimulations to the leads. 4. Lead(s) (Medtronic, Vectris SureScan MRI 1x8 Compact 977A260) A lead is a set of thin wires, covered with a protective coating. A lead has small metal electrodes near the tip. The electrodes transmit electrical pulses to the area where your pain signals are blocked. 5. Recharging Components The recharging component is used to charge the rechargeable Cube battery. Components included in the recharging component are: charger (adapter), and micro-USB cable. Refer to Recharging Cube on page 24 for more information. 8 English M203210201V1.3 2021-Feb Therapies that may not be used with the SCS system

(contraindications) The NeuroBlock SCS system should not be used for those patients who:

Are poor surgical candidates. Fail to receive effective pain relief during trial period. Are unable to operate the SCS system. Risks and benefits It has been proven through research that stimulation can help patients to alleviate and control their pain and thus improve their quality of life. Your spinal cord stimulation system may be used with other pain treatments. Stimulation will not cure your pain. It can, however, reduce your pain to a tolerable level and allow you to resume many of your daily activities. Risks of surgery Implanting a spinal cord stimulation system has risks similar to spinal procedures, including spinal fluid leak, headaches, swelling, bruising, bleeding, infection, or paralysis. If you are on anticoagulation therapy you might be at greater risk for postoperative complications such as hematomas that could result in paralysis. For information about possible adverse effects, refer to Adverse Events on page 40. General Warnings Magnetic Resonance Imaging (MRI) The NeuroBlock SCS System has not been tested under MRI and is currently not labeled as safe. If an MRI scan is required, the clinician must explant and remove all components of the NeuroBlock SCS System. Electromagnetic interference (EMI) Electromagnetic interference (EMI) is a field of energy generated by equipment found in the home, work, medical, or public environments that is strong enough to interfere with NeuroBlock SCS System function. NeuroBlock SCS System include features that provide protection from EMI. However, sources of strong EMI can result in the following:

Serious patient injury or death, resulting from heating of the implanted components of the NeuroBlock SCS System and damage to surrounding tissue. System damage, resulting in a loss of or change in symptom control, and requiring surgical replacement. Operational changes to the NeuroBlock SCS System, causing it to reset and turn off stimulation, which may result in the return of underlying symptoms. Unexpected changes in stimulation, causing a momentary increase in 2021-Feb M203210201V1.3 English 9 stimulation or intermittent stimulation, which some patients have described as a jolting or shocking sensation. Although the unexpected change in stimulation may feel uncomfortable, it does not damage the device or injure the patient directly. In rare cases, as a result of the unexpected change in stimulation, patients have fallen down and been injured. If you suspect that other equipment is interfering with device function:

Move the equipment or object away from the patient. Remove the external stimulator from the vicinity of the patient. Electromagnetic equipment/environments Avoidance of high electro-

magnetic equipment radiators or environments is highly encouraged. Examples of equipment and/or environments include the following:

Highpower amateur transmitters/antennas or citizen band (CB) radio or Ham radio used for private recreation, communication, and wireless experimentation Electric arc welding or resistance welding equipment used for melting and joining metals or plastics Industrial electric induction furnace/heater or electric arc furnace/heater used for melting metals and plastics Highvoltage areas identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area) Microwave transmitters identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area) Television and radio towers identified by fenced areas, restricted access signs, and caution signs (safe if outside the fenced area) Linear power amplifiers used for increasing the power output of radio transmitters, wireless communication applications, audio equipment or other electronic equipment Radio telemetry equipment used for tracking location of vehicles, equipment or animals Computed Tomography (CT) Scanning Please inform your doctor and medical personnel conducting your CT scan that you have an implanted NeuroBlock SCS system. You must not operate any system device(s) while the scan is being conducted. Machinery or heavy equipment Machinery and heavy equipment (including vehicles) should not be operated while using the NeuroBlock SCS System stimulation treatment. Malfunction of the system could result in loss of body control, body function, or a feeling that could render the patient incapable of controlling the system. Case damage If the Implantable Receiver case is ruptured or pierced due to outside forces, the Implantable Receiver fracture may damage the tissue around the Implantable Receiver and unexpected changes in stimulation could result. Diathermy therapy Do not use shortwave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients 10 English M203210201V1.3 2021-Feb implanted with a neurostimulation system. Energy from diathermy can be transferred through the implanted components and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Electrocautery If electrocautery tools are used near the device then the insulation can be damaged. The device may fail or conduct induced currents. Induced electrical currents can cause heating of the Implantable Receiver that results in tissue damage. When electrocautery is necessary, these precautions must be followed:

The Cube should be turned off. Bipolar cautery should be used. If unipolar cautery is necessary:

Only lowvoltage modes should be used. The lowest possible power setting should be used. The current path (ground plate) should be kept as far away as possible from the implanted device. Fulllength operating room table ground pads should not be used. After electrocautery, confirm that the device is working as intended. Psychotherapeutic procedures Safety has not been established for psychotherapeutic procedures using equipment that generates electromagnetic interference (e.g., electroconvulsive therapy, transcranial magnetic stimulation) in patients who have a NeuroBlock SCS System. Induced electrical currents may cause heating, or resulting in tissue damage. NeuroBlock SCS System interaction with active implanted devices or body worn medical devices The NeuroBlock SCS System may interfere with other active implanted medical devices or body worn medical devices, such as deep brain stimulators, peripheral nerve stimulators, transcutaneous electrical nerve stimulation, implanted drug delivery pumps, cardiac pacemakers, defibrillators, cochlear implants, transcranial magnetic stimulation and wearable medical sensors. The effect of other implanted medical devices on the NeuroBlock SCS System are unknown. Theft detectors, security screening devices and radiofrequency identification (RFID) systems Security checkpoints, metal detectors, screening systems at airports, and theft detectors all produce EMI. Any security system device may temporarily interrupt stimulation, or cause elevated levels of stimulation. Patients should avoid performing stimulation treatments in the area of security system devices. It is recommended that if a patient feels a change in stimulation near a potential security system device, they promptly move away from the area and remove the Cube from the body. Patients should not lean on scanners or linger in the area of security system device. Patients with an implanted device should inform the attendant who may be able to assist them in bypassing any abovementioned devices/systems. If unavoidable, the patient should walk through the abovementioned devices/systems and promptly move away from the area. Stimulation at vertebral levels above T8 The safety of implantation of leads implanted above the T8 vertebral level have not been evaluated. 2021-Feb M203210201V1.3 English 11 Pediatric Use The safety and effectiveness of this therapy has not been established for use in children. Pregnancy The safety and effectiveness of this therapy has not been established for pregnancy, nursing, the unborn fetus, or delivery. Wound contact Do Not place the Cube directly on the skin. Direct skin contact may cause irritation and/or sensitivity to the materials. The Cube must be placed overtop a thin layer of clothing at all times. Emergency Procedures The patient should be instructed to designate a representative (family member or close friend) to notify any emergency medical personnel of their NeuroBlock System External Stimulator, if emergency care is required. Each patient will be provided with a Patient Identification Card to carry with them that will inform emergency medical personnel of the patients condition. The patient should be advised to remove the External Stimulator before undergoing any procedure that could include RF or microwave ablation, defibrillation or cardio version. Warnings About Other Medical Treatments/Procedures Safety has not been established for some medical treatments of patient with a stimulator (Implantable Receiver or External Stimulator) and the medical treatments/procedures includes:

Electrolysis Lithotripsy External defibrillation Ultrasound scanning Radiation/Laser therapy Radiofrequency or microwave ablation 12 English M203210201V1.3 2021-Feb Precautions System and therapy Power Percentage Suggestion When performing stimulation, ensure Cube power level is more than 50% to facilitate a smooth operation. Component compatibility For proper therapy, use only GiMER NeuroBlock SCS System components that are prescribed by your clinician. Equipment modification Do not modify this equipment. Modification of this equipment can result in damage to the device, causing the device to malfunction or become unusable. Patient control devices may affect other implanted devices Do not place patient control devices (e.g., Cube, recharging components) over another device

(e.g., pacemaker, defibrillator, cochlear implant, and another spinal cord stimulator). The patient control device could accidently change the operation of another device. Patient device handling To avoid damaging the device, do not immerse it in liquid; do not clean it with bleach, nail polish remover, mineral oil, or similar substances; and do not drop it or mishandle it in a way that may damage it. Patient device use When operating a patient control device (e.g., External Stimulator, Cube, recharging components), use special care near flammable or explosive atmospheres. An interaction between the flammable or explosive atmospheres and the battery in the device could occur. The consequences of using NeuroBlock SCS system near flammable or explosive atmospheres are unknown. Keep the Cube dry The Cube is not waterproof. Keep it dry to avoid being damage. Do not use the Cube when engaging in water activities. Cube interaction with metal Keep the back side of Cube (Wireless Coupling Area) away from any metal for more than 10cm while using Cube during the stimulation therapy of permanent implantation phase. The metal may be coupled with Cube and therefore damage the Cube. Medical tests and procedures Before undergoing medical tests or procedures, contact the clinician to determine if the procedure will cause harm to the patient or damage to the System. Do not dismantle the Cube Do not dismantle or tamper with the device. Tampering with the device could result in harm. Use of another patients Cube Never use another patients Cube. The therapy program level maybe different for each patient. Use of another patients Cube could result in ineffective therapy. Handle the Cube with care The Cube is a sensitive electronic device. Avoid dropping the device onto hard surfaces. Keep the Cube out of the reach of children and pets. 2021-Feb M203210201V1.3 English 13 Storage temperature The Cube should be kept within the storage temperatures listed on product packaging. Exceeding the storage temperature could cause harm to you or the component. Please contact GiMER Medical if a storage temperature is surpassed. Use only GiMER system component The compatibility of components other than GiMer NeuroBlock SCS system defined components is not verified; use only GiMER components unless otherwise specified. Use only with GiMER devices Do not use other non-GiMER wireless communication on the Cube, External Stimulator or Implantable Receiver, and do not use Cube on other non-GiMER devices for wireless power transmission. Unexpected changes in stimulation Electromagnetic interference, changes in posture, and other activities can cause a perceived increase or uncomfortable in stimulation. Some patients have described this as a jolting or shocking sensation. Patients should stop using the NeuroBlock SCS system to administer stimulation before engaging into activities that could become unsafe. Patient activities Activities requiring excessive twisting, pressing or stretching Avoid activities that may put undue stress on the implanted components of your spinal cord stimulation system. Activities that include sudden, excessive, or repetitive bending, twisting, bouncing, pressing, or stretching, such as massaging activities, can cause parts of your spinal cord stimulation system to fracture or migrate. This can result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery. Spinal cord stimulation patients, in particular, should avoid excessive bending of the torso. Component manipulation (twiddlers syndrome) Do not manipulate or rub your spinal cord stimulation system through the skin; this is sometimes called twiddler's syndrome. Manipulation can cause damage to your system, lead dislodgement, skin erosion, or stimulation at the implant site. Scuba diving or hyperbaric chambers Do not dive below 10 meters (33 feet) of water or enter hyperbaric chambers above 2.0 atmospheres absolute (ATA). Pressures below 10 meters (33 feet) of water (or above 2.0 ATA) can damage the spinal cord stimulation system. Before diving or using a hyperbaric chamber, discuss the effects of high pressure with your doctor. Skydiving, skiing, or hiking in the mountains High altitudes should not affect the spinal cord stimulator; however, you should consider the movements involved in any planned activity and take precaution to not put undue stress on your implanted system. During skydiving, the sudden jerking that occurs when the parachute opens can dislodge or fracture the lead, requiring additional surgery to repair or replace the lead. Discuss these activities with your doctor. 14 English M203210201V1.3 2021-Feb Individualization of treatment Best results are achieved when you are fully informed about the therapy risks and benefits, surgical procedure, follow-up requirements, and self-care responsibilities. Maximum benefits from the spinal cord stimulation system require long-term postsurgical management. Patient selection The spinal cord stimulation system should not be implanted if:

your symptoms are not of physiological origin, you are not an appropriate candidate for surgery, you cannot properly operate the system, or you do not receive satisfactory results from trial period stimulation. Use in specific populations The safety and effectiveness of this therapy has not been established for the following:

Pregnancy, unborn fetus, or delivery Pediatric use Longterm effectiveness of neurostimulation The longterm effectiveness of NeuroBlock SCS System has not been established. Longterm clinical data regarding the efficacy of GiMER Medical NeuroBlock SCS System is not yet available. 2021-Feb M203210201V1.3 English 15 3 RECOVERY AND CARE AFTER SURGERY Recovery from surgery It takes several weeks to heal from surgery. It is normal to feel some discomfort from the incision(s) and to have some pain at the implant site for 2 to 6 weeks. Your doctor may also prescribe physical therapy or medication to help manage your pain. Always follow your doctors instructions. Activities Some movements can cause changes in stimulation. For example, leaning back may cause the lead to move closer to your spinal cord; this may result in uncomfortable stimulation. Sudden changes in stimulation are most common while you are recovering from surgery. Avoid activities where you must bend, stretch, or twist your body; these movements can move your leads, which affects your stimulation. Avoid lying on your stomach. Avoid reaching over your head. Avoid turning from side to side. Avoid bending forward, backward, or from side to side. Avoid lifting more than 2 kilograms (5 pounds). As you begin to feel better, you should be able to perform activities such as:

Bathing or showering Sexual activity Working at home or at your business Hobbies or activities, such as walking, gardening, cycling, or swimming Traveling Remember, returning to your daily activities should make you feel better, not worse. Note: As you adjust to life with better pain management, you may want to try activities that you could not perform before your surgery. Discuss your activity level with your doctor. 16 English M203210201V1.3 2021-Feb When to call your clinician Contact your clinician if any of the following events occur:

You have pain, redness, or swelling at the incision(s) later than 6 weeks after surgery. You feel discomfort or pain during stimulation. Pause your stimulation and call your clinician. Your system is not working properly. You cannot start or pause stimulation. You cannot adjust stimulation using the Cube. Your External Stimulator requires battery replacement. Three or more Channel Indicators of your Cube start flashing during stimulation or treatment pause. The stimulation treatment does not effectively relieve your pain. Care schedule Your clinician will schedule follow-up visits to make sure you are receiving the most appropriate therapy. 2021-Feb M203210201V1.3 English 17 4 USING YOUR CUBE How your Cube works The Cube communicates with External Stimulator and Implantable Receiver respectively and wirelessly transfers power to the Implantable Receiver for treatment. Your External Stimulator and Implantable Receiver only accept communications from the Cube, and the communication will only occur after the Cube is paired with External Stimulator or Implantable Receiver. Use the Cube to:

Start or pause your stimulation. View and adjust stimulation levels. View the remaining time for next treatment. Check the battery status. Note: The Cube is an electronic device that should be used in accordance with any restrictions while traveling (e.g., airplane takeoffs). 18 English M203210201V1.3 2021-Feb Cube function keys and indicators Figure 2. Parts of Cube 2021-Feb M203210201V1.3 English 19 The following table provides a description of the functions of the Cube keys. Table 1. Cube Function Keys Function Keys What it does or means Press and hold for 3 seconds to turn on or turn off Cube. When Cube is on, tap the key to see the power status. Press and hold the key for 3 seconds to activate NFC (near field communication) function to establish, or reset communication between Cube and External Stimulator. Tap to synchronize the data for the External Stimulator or Implantable Receiver. Tap Adjustment key to Increase (+) and decrease (-) program level. Power Key Bluetooth Key

(NFC) SYNC Key Adjustment Key Tap to start or pause stimulation. Start/Pause Key 20 English M203210201V1.3 2021-Feb Table 2. Cube Indicators and Outlets Indicators What it does or means Power/Bluetooth Indicator Display device power status and notify if charging is required. Display Bluetooth connection status. Notify when Cube error occurs. Notify when External Stimulator or Implantable Receiver error occurs. level, Display Cube program power level and communication status. Display External Stimulator &

Receiver status (e.g., remaining restriction time or different phase status). Display channels. the status of lead The sound outlet notifications. for audio Cube Error ES/Receiver Error Level Indicators Channel Indicators Audio Outlet 2021-Feb M203210201V1.3 English 21 Connect the charger cable of adapter for power charging. Micro USB Port (capped) 22 English M203210201V1.3 2021-Feb Turn on and off the Cube 1. Press and hold Power key for 3 seconds to turn on the Cube, and there will be several beeps. Power Indicator will flash yellow and blue alternately once. 2. The Cube will perform a self-test (all LED indicators will flash in the sequence of yellow and blue) in a few seconds after Cube turns on. Channel Indicators will light up and then go off. When self-test is completed, the Cube is operational, and Level Indicators will display as blue breathing light. Note: The default setting of Cube is for trial phase; during permanent implantation phase, Level Indicators will display as purple breathing light. 3. Press and hold Power key for 3 seconds to turn off the Cube, and there will 4. All Level Indicators will light up and then go off counter-clockwise now. be beeps. Notes:

Stimulation will stop once the Cube is turned off. When stimulation ends, Cube will automatically turn off after 5 minutes without any operation. 2021-Feb M203210201V1.3 English 23 Cube power status 1. When Cube is on, tap on Power key, Level Indicators of the power level

(e.g., 1 LED indicates 10% power) will light up. 2. If Cube power is insufficient, Power Indicator will start flashing. When the power is below 10% or less, there will be 2 beeps, the Power Indicator will flash in yellow for 5 times, and the Cube will automatically shut down. 3. During stimulation, if Cube runs out of battery, stimulation will stop and the Cube may not communicate with the External Stimulator or Implantable Receiver. Note: To maintain uninterrupted therapy from the External Stimulator or Implantable Receiver, it is advised to recharge the Cube when the battery is lower than 50% (e.g., fewer than 5 LEDs light up). 24 English M203210201V1.3 2021-Feb Recharging Cube For first time use, assemble the adapter by jointing the plug onto the base; follow the arrow direction of Lock to push the plug forward until a click sound is heard.

(Refer to Figure 3) Figure 3. Assemble the Adapter 1. To start a charging session, connect the charger cable included in the Cube package to the micro-USB port at the bottom of the Cube, and plug the power adapter into wall socket (adaptable to 100250V@60Hz). Caution: Do not use any other non-GiMER micro-USB cable and/or adapter to recharge the Cube. Note: Once the Cube starts charging, treatment is NOT available, the Power Indicator LED will remain on in yellow, and go off when the Cube is fully charged. Do not use your Cube during charging session. 2. For checking charging progress, when Cube is operational, tap Power key during the charging session, the current power level will show by flashing the corresponding Level Indicators. 3. For an uninterrupted treatment, allow the Cube to charge until at least five LEDs of Level Indicators lights up (50%); it takes about 2 hours to fully charge the Cube. 4. When the Cube is fully charged, Level Indicators will be off. After tapping the Power key, the Level Indicators will be all on, and the Cube is now ready to be used again. 2021-Feb M203210201V1.3 English 25 Reboot the Cube When the system freezes or hangs and Cube fail to respond to any operation

(including pressing Power key to restart the device, see page 23 ), reboot the Cube by following the below procedures. 1. Press and hold Power key and Start/Pause key together for 10 seconds to reboot the Cube, and Cube will turn on automatically. Caution: Do not reboot the Cube during a charging session, the Cube will be unresponsive to this operation. 26 English M203210201V1.3 2021-Feb 5 USING CUBE TO START STIMULATION DURING TRIAL PHASE After the implantation surgery for placing two leads into your body and connecting External Stimulator with the leads by the clinician, you will receive Cube as a patient controller in the trial phase. Now you are ready to enter a test to see if this therapy works for you. You may refer to Chapter 4 USING YOUR CUBE to learn about Cube and familiarize with the operations better. During trial phase, the stimulation is delivered by the External Stimulator, which is powered by a 9-volt alkaline battery. Under normal circumstance, you will not need to replace the battery of External Stimulator. However, if the battery power is low

(i.e., Power Indicator flashes), contact your clinician to arrange an appointment for battery replacement. There are ten program levels in the Cube. The default level for starting trial phase is level 1, which is the lowest energy level of the program. Most treatment duration is shorter than 10 minutes, but effective throughout the day (even for days) to relieve your pain. After finishing one treatment, Cube will enter restriction period, a new treatment is available every 4 hours in trial phase. The purpose is to moderate your use frequency of the therapy. You can discuss with your doctor about the frequency of using the NeuroBlock SCS System. For the following treatment, the permitted adjustment range is one level up or down from the previous level. (e.g., If you used Level 2 for previous treatment, you may stay in Level 2, or select Level 1 or Level 3 for the current treatment.) Whether to level up or down, it depends on your pain relief condition. If you still feel the pain, you can level up; if you do not feel any pain, (i.e., has found the effective program level), you can stay at the previous level. If you feel the pain at a new area or have complications, please level down or turn off the Cube then call your doctor for help. Figure 4. External Stimulator 2021-Feb M203210201V1.3 English 27 1. Turn on Cube and ensure Cube is operational (all Level Indicators will display as blue breathing light). Keep the Cube within 3 meters (10 feet) of the External Stimulator, tap SYNC key to synchronize Cube with External Stimulator. For the first use, the default program level is Level 1 and 1 LED will light up in blue. Note: After tapping SYNC key, if it is still within restriction time, Level Indicators will flash in yellow for the percentage of remaining time (e.g., 1 LED indicates 10% of 4 hours of trial phase restriction, which is 24 minutes). Note: After tapping SYNC key, if the External Stimulator battery is low, the ES Power Indicator on the upper right-hand corner of External Stimulator and the ES/Receiver Error on Cube will begin to flash. Caution: Contact your clinician to arrange an appointment for battery replacement, do not try to replace the battery on your own. 2. After the synchronization is completed, there will be beeps, Level Indicators will display the last treatment level by lighting up the corresponding light in blue. Channel Indicators will light up for operational channels. Program level can be adjusted by tapping Adjustment Key to increase or reduce the stimulation intensity. (Skip this step, if the adjustment is not needed.) Level Up (Increase Strength): Tap +, and the corresponding Level Indicators will Level Down (Reduce Strength): Tap -, and the corresponding Level Indicators will begin to flash. begin to flash. Caution: If it is noticed that three or more Channel Indicators of your Cube start flashing or didnt light up, contact your doctor immediately. Note: The range of allowed level adjustment for each treatment during trial phase is one level up or down, you may also stay in current level. 3. When the desired level is selected, tap SYNC key first, after synchronization is finished, Level Indicators will light up in blue for the selected level, and then tap Start/Pause key to begin the stimulation. Now Level Indicators will light up in yellow and display the treatment remaining dosage by going off counterclockwise, and there will be 1 long beep at the beginning, and then 1 short beep every 5 seconds during the treatment. Note: It is advised to keep in upright and sitting position, and avoid any movements during the stimulation. 28 English M203210201V1.3 2021-Feb Figure 5. External Stimulator location during Trial Phase 4. To pause the stimulation as needed, tap Start/Pause key again. Level Indicators will flash in blue and yellow alternately and then display blue breathing light for the program level during the pause, and Channel Indicators will light up. To resume the treatment, tap Start/Pause key again. Notes:

During a treatment, if Bluetooth connection is lost, External Stimulator will automatically postpone the treatment and wait for reconnection, Cube Power/Bluetooth Indicator will start flashing in blue and yellow alternately (for reconnecting Bluetooth ). Once Cube and External Stimulator reconnected, there will be beeps, Power/Bluetooth Indicator will flash in blue, Level Indicators will display the corresponding program level in blue light, then tap Start/Pause key to resume the treatment. If Cube fails at Bluetooth reconnection and idles (without any operation) for 1 minute, Cube will return to standby mode, and Level Indicators will display blue breathing light. Tap SYNC key to reconnect the External Stimulator. If reconnection fails, press and hold Bluetooth key to TROUBLESHOOTING on page 37. If the Bluetooth connection still fails to resume, then leave the current environment since the failure might be due to EMI

(electromagnetic interference). reset Bluetooth . Refer to When treatment is paused for over 30 seconds, or, if accidentally SYNC key is pressed for 5 seconds during the pause, the Cube will return to standby mode, Level Indicators will display as blue breathing light. For resuming the unfinished treatment, tap SYNC key again to enter stimulation mode, Level Indicators will display blue breathing light for the program level paused, and then tap Start/Pause key again to start the stimulation; level adjustment is not allowed for the unfinished treatment. After five more minutes, Cube will automatically turn off itself without any operations. To continue the unfinished treatment, repeat step 1 and tap Start/Pause key. 2021-Feb M203210201V1.3 English 29 5. When a treatment finishes, there will be beeps and the Level Indicators will flash blue and yellow interweavingly, then the Cube enters the restriction period for next treatment (4 hours during trial phase). The Level Indicators of Cube will display as breathing lights in blue. 6. After the restriction time ends, repeat step 1 to 3 for a new treatment if needed. Notes:

During restriction, to know the remaining time for next treatment, turn on the Cube and when Cube is operational, tap SYNC key, and Level Indicators will flash in yellow for the percentage of remaining time (e.g., 1 LED indicates 10% of 4 hours of restriction, which is 24 minutes). Restriction period begins once stimulation is started. If the stimulation is paused, it can be resumed any time before the restriction period ends. The paused or unfinished treatment will be omitted after a restriction period ends, and a new treatment can be started as step 1 to 3. When stimulation ends, Cube will automatically turn off after 5 minutes without any operation. Change External Stimulator battery: In rare cases, if External Stimulator power is insufficient, ES/Receiver Error on Cube will flash in a fast speed. Contact your clinician. 30 English M203210201V1.3 2021-Feb 6 USING CUBE TO START STIMULATION DURING PERMANENT IMPLANTATION PHASE After going through trial phase, it has been proven that this therapy works for you, and you must be very familiar with your Cube that you know how to turn Cube on and off, start and control the treatment. Now moving forward to next phase, with two leads and an Implantable Receiver implanted in your body, the operation of Cube remains the same, though you are advised to utilize the belt, pads and pouch assembly to support the Cube for aligning with the Implantable Receiver during the treatment. If you encounter any difficulty hearing the beeps or operating system device, please request assistance from your family member, friend, caregiver, or healthcare professionals. You are advised to wear a thin layer of clothing for the treatment, and keep Cube away from any metal for more than 10cm distance. During the therapy, maintain yourself in an upright and sitting position, and avoid any movements. Implantable Receiver generates heat during the stimulation, your skin at the implant site may feel warm during the treatment, though it does not cause harm, please stop the treatment should you feel any discomfort, and contact your doctor immediately. During permanent implantation phase, the stimulation is delivered by the Implantable Receiver, which is a battery-free device, powered by the energy transmitted wirelessly from the Cube. The battery-free feature not only ensures more safety, but also means your Implantable Receiver does not need charging session and maintenance. Under normal circumstance, you wont have to go through another surgery due to replacement of a depleted device battery. There are ten new program levels in the Cube. Normally, each treatment duration is shorter than 10 minutes, but effective throughout the day (even for days) to relieve your pain. After finishing the treatment, Cube will enter a restriction period. During permanent implantation phase, a new treatment is available every 6 hours, the purpose is to moderate your use of the therapy. You can discuss with your doctor about the frequency of using this pain therapy. 2021-Feb M203210201V1.3 English 31 Figure 6. Implantable Receiver 1. Turn on the Cube, and when Cube is operational (all Level Indicators will display as purple breathing light), tap SYNC key to activate stimulation mode, Level Indicators of the previous program intensity will light up in blue. For the first use in the permanent implantation phase, the default program level is level 5. Note: If it is still within restriction time, Level Indicators will flash in yellow for the percentage of remaining time (e.g., 1 LED indicates 10% of 6 hours of permanent implantation phase restriction, which is 36 minutes). 2. Select desired level by tapping Adjustment key to choose level strength.

(Skip this step, if the adjustment is not needed.) Level Up (Increase Strength): Tap +, and the corresponding Level Indicators will Level Down (Reduce Strength): Tap , and the corresponding Level Indicators will light up. light up. 32 English M203210201V1.3 2021-Feb Figure 7. Belt and pouch assembly Figure 8. Align and attach pouch to the belt 3. Put on the belt with Velcro area (velvet at inner side of the belt) facing the body, buckle up, fasten the belt by adjusting the belt length, and tuck the excess belt in a knot. The belt should cover the implantation site. 4. Tap Start/Pause key, and place the Cube into the pouch, then attach the pouch Velcro area (hook) to the belt Velcro area (velvet at inner side of the 2021-Feb M203210201V1.3 English 33 belt), where the Cube is at the inner side of belt and face outward, and the pouch front should be aligned with the upper seam of the belt (refer to Figure 7 and Figure 8). Note: Insert the pads in the small pocket at the pouch to increase the proper distance for optimal communication between Cube and Implantable Receiver. Your clinician or nurse might have chosen the suitable pad for you before you left hospital. 5. Adjust the belt to allow Cube align with Implantable Receiver implantation site (refer to Figure 9 and Figure 10), there will be 2 short beeps repeatedly every 2 seconds; when Cube detects Implantable Receiver in the proximity, there will be repeated short beeps. When Cube is properly aligned with Implantable Receiver, there will be a long beep indicating the beginning of the treatment, and a short beep every 5 seconds during the treatment, maintain your position and avoid movements during the process. Cautions:

While aligning Cube with Implantable Receiver or during stimulation treatment, do not suddenly remove Cube away from Implantable Receiver, and you should avoid any abrupt movement. If it is necessary to change the device relative position, tap Start/Pause key first for pausing the communication between the two devices to prevent the prickling sensation caused by the surge of transient power. Note: After tapping Start/Pause key, Level Indicators will flash in blue light back and forth when Cube is searching for Implantable Receiver, and when Cube detects Implantable Receiver in the proximity, Level Indicators will flash clockwise in blue and counterclockwise in yellow, and then flash in blue and yellow alternately when Cube is establishing communication connection with Implantable Receiver. Figure 9. Align pad area with Implantable Receiver 34 English M203210201V1.3 2021-Feb Figure 10. Stimulation during permernent implantation phase 6. During the treatment, Level Indicators will light up in yellow and reduce counterclockwise to display remaining dosage, and Channel Indicators of the lead(s) in use (operational channels) will light up. 7. Tap Start/Pause key to pause the treatment as needed; during the pause period, Level Indicators of the programmed intensity will display as blue breathing light, and Channel Indicators of operational channels will light up. Tap Start/Pause key again can resume the treatment. Cautions:

If it is noticed that three or more Channel Indicators of your Cube start flashing during stimulation, or treatment pause, or after a treatment is complete, contact your doctor immediately. In rare cases, the temperature of Implantable Receiver may rise to maximum 43.5C during stimulation. Although no damage will be caused, if the heat is unbearable or you feel any discomfort, stop the treatment and contact your doctor immediately. Notes:

During a treatment, if wireless communication is lost, Level Indicators will display as blue light repeatedly flashing clockwise, and there will be two short beeps repeatedly. Cube will automatically postpone the treatment and reconnect Implantable Receiver proactively. Once Cube and Receiver reconnected, there will be 3 beeps, Level Indicators will light up in blue for the treatment level, and after a long beep, treatment will be automatically resumed. 2021-Feb M203210201V1.3 English 35 If Cube fails to reconnect for 1 minute, repeat step 1 to 5 to reconnect the Implantable Receiver. If the reconnection still fails, make sure the Implantable Receiver and the Cube are aligned to each other or leave the current environment since the failure might be due to EMI (electromagnetic interference). 8. When the treatment is complete, there will be 6 beeps, Level Indicators will light up in blue for the finished program level, and Channel Indicators will light up for the channel just used. Abnormal channel(s) will flash if theres any open channel or impedance error. Cube enters the restriction period for next treatment (6 hours during permanent implantation phase). Then, Level Indicators of Cube will display as breathing lights in purple. 9. After the restriction time ends, repeat step 1 to 8 for a new treatment if needed. Notes:

During restriction, to know the remaining time for next treatment, turn on the Cube and tap SYNC key, and Level Indicators will flash in yellow for the percentage of remaining time (e.g., 1 LED indicates 10% of 6 hours of permanent implantation phase restriction time, which is 36 minutes). Restriction period begins once stimulation is started. If the stimulation is paused, it can be resumed any time before the restriction period ends. The paused or unfinished treatment will be omitted after a restriction period ends, and a new treatment can be started. When stimulation ends, Cube will automatically turn off after 5 minutes without any operation (inactivity). 36 English M203210201V1.3 2021-Feb 7 TROUBLESHOOTING If you are experiencing problems with your Cube, use the below table for troubleshooting. It also provides information on when to call your clinician. Note: If you cannot solve a problem or if your problem is not described here, contact your clinician. Table 3. Troubleshooting Problem Description Uncomfortable stimulation:

Possible Reasons:

The selected stimulation level is not suitable for your current activity or posture. Possible Solutions:

Stop the stimulation. Stop the activity. Change your current posture and keep in upright sitting position. If this does not eliminate the problem, call your clinician. cannot Cube communicate wirelessly External Stimulator with Possible Reasons:

Refer to "USING CUBE TO START STIMULATION DURING TRIAL PHASE" on page 27 for what the Cube displayed. You are in an environment where multiple devices are using Bluetooth and thereby creating interference. You have moved into an environment where the use of Bluetooth is prohibited. External Stimulator battery level is low. Possible Solutions:

Make sure that the Cube and External Stimulator are within range of each other (within 3 meters). Make sure Cube is not in an environment of EMI (electromagnetic interference) or in a Bluetooth prohibited environment. Tap SYNC key to reconnect the External Stimulator. Install a new battery for the External Stimulator (contact your clinician for battery replacement). cannot Cube with communicate Implantable Receiver Refer to " USING CUBE TO START STIMULATION DURING PERMEMANT IMPLANTATION PHASE" on page 30 for what the Cube displayed. Possible Reasons:

Connection timeout and Cube idles. Cube is not properly aligned with Implantable Receiver within proper distance and/or the communication is out of range. 2021-Feb M203210201V1.3 English 37 Possible Solutions:

If Cube idles, tap SYNC key, Level Indicators will become purple breathing light, and tap SYNC again, if Level Indicators light up in blue for program level, tap Start/Pause key to start the treatment. Make sure the Cube is aligned with the implantation site of Implantable Receiver with proper communication distance and range

(using belt set and pad for support). Possible Reasons:

Possible Solutions:

Cube error occurs during the treatment in permanent implantation phase

(ES/Receiver Error lights up with two short beeps repeatedly) Cube contacts or comes near metal objects while communicating with Implantable Receiver Keep Cube away from the metal object for more than 10cm distance. Tap SYNC key, Level Indicators will display as purple breathing light, then tap SYNC key again, Level Indicators will display breathing light in blue for the program level, tap Start/Pause key to resume the treatment. Implantable Receiver Overheating

(ES/Receiver Error and Level Indicators flash in yellow with two short beeps repeatedly) Possible Reasons:

Possible Solutions:

If the temperature of the Implantation Receiver rises to 43.5C, the treatment will pause, and ES/Receiver Error and Level Indicators will flash in yellow with 2 short beeps repeated. Tap SYNC key, Level Indicators will display as purple breathing light, and wait until the temperature drops (it is suggested to wait for about 20 minutes), then tap SYNC key again, Level Indicators will display breathing light in blue for the program level, tap Start/Pause key to resume the treatment. Cube battery level is low It is advised to recharge the Cube when the battery is lower than 50%

for an uninterrupted treatment. Charge the Cube by using the recharging components. Refer to Recharging Cube on page 25. Cube is unresponsive Possible Solutions:

(Cube Error lights up) Turn off the power for the Cube, then turn the power back on.

(Reboot the Cube if the system is hung or frozen; refer to Reboot the Cube on page 26.) After rebooting, if Cube Error persists and there are 2 short beeps repeat for a few seconds, contact your clinician If you continue to have communication problems or cannot use the Cube to control stimulation, contact your clinician or GiMER representative using the contact information listed on the inside back cover of this manual. 38 English M203210201V1.3 2021-Feb Dropped Cube: Your Cube falls off a cabinet or table Possible Solutions:

Turn on the Cube to verify if all operations and indicators are normal;

if the Cube is severely damaged, contact GiMER representative to arrange for a replacement. The Cube is designed to withstand a short drop to a hard surface and still operate normally, even if the case is chipped or nicked. Fluid on the Cube:

Fluid was spilled onto the Cube or the Cube was dropped into water Possible Reasons:

Possible Solutions:

Cube is not waterproof, and water can damage the device. If fluid was spilled onto Cube case, pat dry the Cube with dry and clean towel and allow the Cube to air dry at room temperature. If Cube was dropped into water, contact GiMER representative to arrange for Cube replacement. If the Cube requires repair, is damaged, or is nonfunctional and a replacement is needed, contact your GiMER representative using the contact information listed on the inside back cover of this manual. 2021-Feb M203210201V1.3 English 39 8 ADDITIONAL INFORMATION Adverse events The implantation of a spinal cord stimulation system involves risks that are similar to other SCS system. In addition to those risks associated with surgery, the adverse events may occur with implantation or use of a NeuroBlock SCS system and underlying disease progression include but are not limited to the following. Please contact your physician if you experience any adverse events associated with the NeuroBlock SCS system. Abscess Allergic or rejection response to the implanted materials Cerebral spinal fluid (CSF) leakage Clumsiness Death Electrical shock, neurological effect, prickling, numbness, and/or uncomfortable sensation from stimulation Epidural hemorrhage Escalating pain symptoms Fibrosis Formation of reactive tissue around the lead in the epidural space Hyperesthesia Infection Inflammation/swelling Intermittent stimulation Lead migration(movement) Nerve damage Neurological deficits Neurostimulator pocket pain, infection, inflammation, hematoma, seroma, bleeding, and/or erosion Numbness Pain, bleeding, inflammation, and/or infection at the epidural needle insertion site Pain caused by overstimulation Pain caused by under stimulation Pain from a non-noxious stimulus to the skin (allodynia) Paralysis Persistent pain at the site of the implanted components Spinal cord compression Stimulation of the chest wall (radicular stimulation) Stimulation-dependent gastrointestinal symptoms such as diarrhea, incontinence, or constipation. Stimulation-dependent bladder symptoms such as urinary retention, incontinence, or frequency. Thrombosis (blood clot) Tissue damage 40 English M203210201V1.3 2021-Feb Sensation of hearting or burn at the implant site Weakness Subjects may require surgery. including revision, explant, and/or NeuroBlock system component replacement as a result of any of the above events. Possible system complications The lead, or Implantable Receiver could migrate within the body or erode through the skin. There could be undesirable changes in stimulation, possibly related to cellular changes around the electrode(s), changes in the position of the electrode(s), loose electrical connections, or lead fractures. It is also possible that the implanted materials could cause an allergic or immune system response. Your spinal cord stimulation system might unexpectedly cease to function due to other causes. These events, which can include electrical shorts or open circuits, conductor (wire) fractures, and insulation breaches, cannot be predicted. 2021-Feb M203210201V1.3 English 41 9 MAINTAINENCE AND ASSISTANCE This section provides information how to care for your Cube, and instructions on using accessories. This section also provides Cube specifications and information about who to call for assistance. Cleaning and care Follow these guidelines to ensure that the Cube and accessories function properly. Cautions:

Keep the Cube out of the reach of children and pets. If children or pets swallow any components, contact a doctor at once. Use the SCS system components only as explained to you by your clinician or as discussed in this manual. Handle the Cube with care. Do not drop, strike, or step on the Cube. Do not dismantle or tamper with the Cube. Do not sterilize any parts of the Cube, sterilization may damage the Cube. Keep Cube away from any metal objects during therapy in permanent implantation phase. The Cube is not waterproof. Do not allow moisture to get inside the device. Use only dry and clean towel to wipe clean the Cube. Safety and technical checks Periodic safety and technical checks or periodic maintenance of the Cube are not required. The Cube contains no user- serviceable parts. If repair or service is needed, contact your clinician or a GiMER representative for a replacement. Refer to the GiMERs contact information at the end of this manual. Battery, Cube, and External Stimulator disposal Return your Cube and your External Stimulator to your doctor or GiMER representative at the end of the trial phase or when no longer being used. Do not discard or burn the Cube or External Stimulator. Fire may cause the internal batteries of the Cube and External Stimulator to explode. Do not attempt to dispose of the Cube or External Stimulator yourself. Implantable Receiver disposal Explanted Implantable Receiver should not be resterilized or re-implanted. We suggest your explanted Implantable Receiver be returned to doctor or GiMER representative. Refer to the back cover for contact information if you or your doctor have any questions. 42 English M203210201V1.3 2021-Feb Specifications The following table lists the specifications for the External Stimulator and Cube. Table 4. Material of Model 1001 External Stimulator Component Material Material contacts human tissue Case Cover Contacts Pad Accessory Battery Description Connector type Height Width Thickness Weight Polycarbonate Polycarbonate Gold-

beryllium copper and nickel-plated Foam PP3 9V alkaline battery Yes No No No No Table 5. Physical Characteristics of Model 1001 External Stimulator 2 Octapolar, 16 electrodes contact Value 81 mm 68 mm 22 mm 150 g 10C to 40C

-10C to 55C 30% to 90%

75 to 150 kPa 1 year Power source PP3 9V alkaline battery Degree of protection against electrical shock Type BF Operating temperature range Storage temperature range Humidity Pressure ES Service Life 2021-Feb M203210201V1.3 English 43 Table 6 . Physical Characteristics of Model 2032 Cube Operation temperature range Storage temperature range Description Power Source Service life Humidity Pressure Weight User assistance Rechargeable lithium battery Value 1 year 10C to 40C

-10C to 55C 30% to 90%

75 to 175 kPa 250 g Size (approximate) 65 mm x 123 mm x 21.5 mm If repair or service is needed, contact your clinician or GiMER representative. Refer to the GiMER contacts at the end of this manual. The serial number is located in the backside of the Cube. This number identifies each Cube. If you contact GiMER or GiMER representative about your Cube, refer to the serial number. If your Cube stops working First try the steps in "TROUBLESHOOTING" on page 37. Otherwise, contact GiMER representative or your clinician. If you lose your Cube Contact GiMER or your clinician to order a new Cube. 44 English M203210201V1.3 2021-Feb

(MR) IEC60601-1/EN60601-1, BF FCC Information Bluetooth SIG The following is communications regulation information on the Model 1001 External Stimulator. M203210201V1.2 2021-2 45 i xx xx xx xx N FCC ID:

This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:

(1) This device may not cause harmful interference, and (2) This device must accept any interference received, including interference that may cause undesired operation. 46 M203210201V1.3 2021-2

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() 65 mm x 123 mm x 21.5 mm 78 86 M203210201V1.3 2021-2 2021-2 M203210201V1.3 87 88 M203210201V1.3 2021-2 9F-7,No. 97, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 22175, Taiwan Manufacturer GiMER Medical Ltd. Co. www.GiMERmed.com Tel. +886-2-2697-2680 Fax. +886-2-2697-2670 22175, www.GiMERmed.com

. +886-2-2697-2680

. +886-2-2697-2670 9797

@GiMER Medical. 2020. All Rights Reserved M203210101V1.3

THESE DRAWINGS AND SPECIFICATIONS ARE THE SOLE PROPERTY OF GIMER MEDICAL CO., LTD., AND SHALL NOT BE REPRODUCED, COPIED, OR USED IN ANY MANNER WITHOUT THE PRIOR WRITTEN CONSENT OF GIMER MEDICAL CO., LTD. OR ITS AFFILIATED SUBSIDIARIES. TITLE:

DRAWN:

DATE CUBE CASE LABEL CY CHENG 26//01/2021 GiMer Med. CO., Ltd. TAIWAN, R.O.C. TEL: +886-2-26972680 DWG No:

6-2032-DCL-101 REV. 0.2 SHEET 1 /

1 CHECKED:

APPROVED:

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Gimer medical co.,Ltd 9F.-5&-6, No.97, Sec. 1, Xintai 5th Rd., Xizhi Dist., New Taipei City 221, Taiwan Federal Communications Commission Equipment Authorization Branch 7435 Oakland Mills Road Columbia, MD 21046 Date: 2021-01-26 Request for Long-Term Confidentiality Company name: Gimer medical co.,Ltd FCC ID: 2AYGA2032 FCC Part 15 Certification To whom it may concern:

In accordance with 0.457(d) and 0.459 of CFR 47, Gimer medical co.,Ltd hereby requests Long-Term confidentiality of all Block Diagrams, Schematics, Operational Description attachments for the subject application. These documents contain detailed system and equipment description and related information about the product which Gimer medical co.,Ltd considers to be proprietary, confidential and a custom design and otherwise would not release to the general public. Since the design is a basis from which future technological products will evolve, Gimer medical co.,Ltd considers that this information would be of benefit to its competitors and that the disclosure of the information in these documents would give competitors an unfair advantage in the market. Sincerely, iT C Signature , Name: Chanyi Cheng Title: Quality Assurance Manager Company: Gimer medical co.,Ltd