# Nalu™ Medical, Inc. ## NALU™ NEUROSTIMULATION SYSTEM ## MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION *It is important to read this entire manual prior to conducting or recommending an MRI examination on a* *user implanted with the Nalu Neurostimulation System. These instructions only apply to the Nalu* *Neurostimulation System and do not apply to other products. If you have any questions, please contact* *Nalu Medical or visit www.nalumed.com.* Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information- PN: MA-000105 Rev A --- # TABLE OF CONTENTS ## INTRODUCTION ... 3 ## HEAD AND EXTREMITY MRI LABELING ... 5 ## SCS HEAD AND EXTREMITIES SCAN USING A TRANSMIT/RECEIVE HEAD AND EXTREMITIES ... 5 ## PNS HEAD AND EXTREMITIES SCAN USING A TRANSMIT/RECEIVE HEAD AND EXTREMITIES ... 10 ## WHOLE-BODY MRI LABELING ... 11 ## HOW TO DETERMINE THE PATIENT’S WHOLE-BODY MR CONDITIONALITY ... 11 ## DEVICE CONFIGURATIONS ... 13 ## NERVE TARGET ... 14 ## SINGLE LEAD LOOK-UP TABLE ... 24 ## DUAL LEAD LOOK-UP TABLE ... 29 **LABELS ... 46** **APPENDIX A ... 172** **WHOLE-BODY MRI QUICK REFERENCE GUIDE ... 172** **CONTACT INFORMATION ... 173** Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 2 of 173 --- # INTRODUCTION *The following information applies to all MR Conditional labels contained in this manual.* ## All the components of the Nalu Neurostimulation System are MR Unsafe except for the following: - *Nalu Implantable Pulse Generator Dual 4 Ported (Model 11007-002) connected to one or two 25* *cm Nalu Tined Leads (Model 12005-025)* - *Nalu Implantable Pulse Generator Dual 4 Ported (Model 11007-002) connected to one or two 40* *cm Nalu Tined Leads (Model 12005-040)* - *Nalu Implantable Pulse Generator Dual 4 Ported (Model 11007-002) connected to one 25 cm* *Nalu Tined Leads (Model 12005-025) and one 40 cm Nalu Tined Leads (Model 12005-040)* - *Nalu Implantable Pulse Generator Dual 8 Ported (Model 11004-002) connected to one or two 40* *cm Nalu Multilumen Leads (Model 12001-040)* - *Nalu Implantable Pulse Generator Dual 8 Integrated, 40 cm (Model 11002-040)* - *Nalu Implantable Pulse Generator Alternate Pitch Dual 8 Ported (Model 11009-002) connected to* *one or two 40 cm Nalu Alternate Pitch Leads (Model 12010-040)* - *Nalu Implantable Pulse Generator Single 4 Ported (Model 11006-002) connected to a 25 cm Nalu* *Tined Lead Model (12005-025)* - *Nalu Implantable Pulse Generator Single 4 Integrated, 25 cm Tined (Model 11005-025)* - *Nalu Implantable Pulse Generator Single 4 Ported (Model 11006-002) connected to a 40 cm Nalu* *Tined Lead (Model 12005-040)* - *Nalu Implantable Pulse Generator Single 4 Integrated, 40 cm Tined (Model 11005-040)* - *Nalu Implantable Pulse Generator Single 8 Ported (Model 11003-002) connected to a 40 cm Nalu* *Multilumen Lead (Model 12001-040)* - *Nalu Implantable Pulse Generator Single 8 Integrated, 40 cm (Model 11001-040)* - *Nalu Anchor (Model 13001).* **WARNING** **Do not bring MR Unsafe components of the Nalu Neurostimulation System into the MRI** **system room.** ## Additional conditions for all MRI Examinations - Do not perform MRI if the patient has a device or device component lead(s), extension, etc. attached to the Nalu Implantable Pulse Generator or leads from a different manufacturer attached to the Nalu Implantable Pulse Generator. The risk of performing an MRI examination under those circumstances has not been evaluated and, thus, may cause harm to the patient and/or the components. - Nalu Neurostimulation System external components are not allowed in MRI system room. These components include Therapy Discs (Model 34001 or Model 34002), the iOS™ or Android™ device with the Nalu Remote Control application, Charger, Clinician Programmer and Belts, surgical instruments or accessories. All such parts are MR Unsafe and are not permitted in the MRI system room. - Do not perform MRI on a patient undergoing the trial phase of the Nalu Implantable Pulse Generator (i.e., the patient has a percutaneously implanted lead and an external Trial Therapy Disc (Model 34002). Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 3 of 173 --- - Do not perform MRI on a patient that has any other active medical implants. ## Preparation of the Patient Prior to the MRI Examination - Inform the patient of the risks associated with undergoing an MRI examination: an MRI exam performed outside recommended guidelines may result in the electromagnetic fields used with MRI technology interacting adversely with an implanted Nalu Neurostimulation System, potentially injuring the patient and/or damaging the device. - A trained healthcare professional with the proper knowledge of MRI technology such as an MRI safety-trained radiologist, MRI technologist, MRI nurse, or MRI physicist must ensure that the MRI examination will be conducted according to the information presented in this document. - Perform an impedance check. Do not perform an MRI if the impedance is greater than 10 kΩ. - Remove the Therapy Disc from the patient before entering the MRI system room. - Do not conduct an MRI examination if the implanted lead(s) are not connected to the Nalu Implantable Pulse Generator. - Do not sedate or anesthetize the patient so that the patient can inform the MRI system operator of any unusual sensations or problems associated with the MRI examination. - Instruct the patient to immediately inform the MRI system operator if any discomfort, stimulation, shocking, or heating is experienced during MRI. ## Additional Preparation of Patients with more than one Nalu Neurostimulation System - If the patient has more than one implanted Nalu Neurostimulation System, there must be a minimum distance of 50 mm between any part of the systems (IPG and lead(s)). Do not perform an MRI examination on a patient if there is less than 50 mm between the implanted systems. - If the Nalu Neurostimulation Systems are implanted in different body regions, it can be assumed that there is at least 50 mm between the systems. The body regions, as referred to above, are defined as the head, neck, torso, upper extremities, and lower extremities. - If the Nalu Neurostimulation Systems are implanted in the same body region, the distance between the systems must be confirmed before the MRI examination. The distance should be confirmed through imaging, such as fluoroscopy or X-Ray. ## Considerations during the MRI Examination - Similar to other MRI examinations, carefully monitor the patient throughout the MRI procedure both visually and audibly. Immediately discontinue the MRI examination if the patient reports any problems or unusual sensations. ## Considerations after the MRI Examination - After the patient leaves the MRI system room, turn the Therapy Disc on and verify connection to the Implantable Pulse Generator. - Perform an impedance check. Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 4 of 173 --- HEAD AND EXTREMITY MRI LABELING SCS Head and Extremities scan using a transmit/receive head and extremities MR Conditional MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu Neurostimulation System may be safely scanned anywhere in the body at 1.5 T under the following conditions. Failure to follow these conditions may result in injury. Parameter Condition | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_0$) | 1.5T or 3.0T | | MR Scanner Type | Cylindrical | | $B_0$Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20T/m(2000gauss/cm) | | Maximum Gradient Slew Rate | 200T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Head and Extremity | | Receive Coil Type | Head and Extremity | | RF Conditions | First Level Controlled-Partial body SAR of the exposed body part of10W/kgand HeadSAR of3.2W/kg | | Scan Duration | Scan for up to15 minutes. | | Scan Regions | For head/brainMRI examinations,only the transmit/receive RF head coil is permittedfor use.No parts of the implanted NaluNeurostimulationSystem may be within the transmit/receive RF head coil. | | For extremity MRI examinations,only use a transmit/receive RF coil that includesa knee,foot/ankle,or wrist transmit/receiveRF coil.No part of the implanted NaluNeurostimulationSystem may be within oneof these transmit/receive RF coils. | | | Image Artifact | In non-clinical testing,the image artifact causedby the NaluNeurostimulationSystem extends approximately10mm fromthis implant when imaged using a gradientecho pulse sequence and a3TMRI system. | Important Note: An MRI examination performed outside these guidelines may result in the electromagnetic fields used with MRI technology to interact adversely with an implanted Nalu Neurostimulation System potentially injuring the patient and/or damaging the device. Due to the risks of using MRI in a patient with an active implanted device, it is important to read, understand, and comply with all instructions to prevent potential harm or injury to the patient and/or damage to the device. --- Acceptable 1.5 T/64-MHz or 3 T/128 MHz MRI Scenarios **Note the position of the implantable pulse generator (IPG) and leads relative to the transmitted RF** **energy for each respective transmit/receive RF coil.** ## Head/Brain MRI Examination Transmit / receive RF head coil 1.5 T or 3 T MR system Patient implanted with Nalu Neurostimulation System **Figure 1. Head/brain MRI examinations are permitted using a 1.5 T or 3 T MRI system and a** transmit/receive RF head coil. No part of the implanted Nalu Neurostimulation System may be within the transmit/receive RF head coil. All other aforementioned conditions must be carefully followed. Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 6 of 173 --- ## Extremity MRI Examinations Patient implanted with Nalu Neurostimulation System Transmit/receive RF knee coil 1.5 T or 3 T MR system **Figure 2a** Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 7 of 173 --- Patient Implanted with Nalu Neurostimulation System 1.5 T or 3 T MR system Transmit/receive RF foot/ankle coil **Figure 2b** Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 8 of 173 --- Patient implanted with Nalu Neurostimulation System Transmit/receive RF wrist coil 1.5 T or 3 T MR system **Figure 2c** **Figure 2. Extremity MRI examinations are permitted using a 1.5 T or 3 T MRI system and a** transmit/receive RF extremity coil (e.g., knee, foot/ankle, wrist). No part of the implanted Nalu Neurostimulation System may be within the transmit/receive RF extremity coil. All other aforementioned conditions must be carefully followed. (a) Represents an MRI of the knee using a transmit/receive RF knee coil. (b) Represents an MRI of the foot or ankle using a transmit/receive RF foot/ankle coil. (c) Represents an MRI of wrist using a transmit/receive RF wrist coil. Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 9 of 173 --- PNS Head and Extremities scan using a transmit/receive head and extremities MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu --- # WHOLE-BODY MRI LABELING ## How to Determine the Patient’s Whole-Body MR Conditionality This manual walks through a series of questions about the patient’s implant to generate a lead code, unique to each implanted lead. If the patient has one implanted lead, one lead code will be generated. If the patient has two implanted leads, two lead codes will be generated. This lead code will then be used to determine what Whole-Body MR conditionality applies to the patient. Step 1 – Select the Device Configuration Using the Device Configuration table on page 13, find the number that corresponds to the implanted IPG and lead. This number is the patient’s device code and the first digit of the patient’s lead code. If the patient has two leads connected to the IPG, repeat Step 1 through 3 for each lead. If the implanted IPG and lead combination does not appear in the Device Configuration table, then it is MR Unsafe. *Example 1a: The patient has a Dual 4 Ported IPG (11007-002) with a 25 cm Tined Lead (12005-025), so* the patient’s device code is 1-. *Example 1b: The patient has a Single 8 Ported IPG (11003-002) with a 60 cm Multilumen Lead (12001-* 060), so it is MR Unsafe. Step 2 – Select the Nerve Target After selecting the implanted Device Configuration, go to list of Nerve Targets on page 14, and select the nerve being stimulated by the lead. This will lead to a decision tree applicable to the patient’s Nerve Target. If the nerve being stimulated by the lead is not listed, then it is MR Unsafe. *Example 2a: The patient’s lead is stimulating the Axillary nerve, so the applicable decision tree is on page* 15. *Example 2b: The patient’s lead is stimulating the Ilioinguinal nerve, which is not present on the Nerve* Target list, so it is MR Unsafe. Step 3 – Select the IPG Location and Orientation of the Lead’s Stimulating Contacts After selecting the Nerve Target and navigating to the page containing the applicable decision tree, answer the questions in the decision tree to find the patient’s implant code. This implant code will be the last two digits of the patient’s lead code. The first question asks where the IPG is implanted. If the IPG implant location is not listed or uncertain, select “Other.” The second question asks what the orientation of the lead’s stimulating contacts is. If the orientation is not clear, select “Uncertain.” Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 11 of 173 --- *Example 3a: The patient has a Single 8 Ported IPG (11003-002) with a 40 cm Multilumen Lead (12001-* 040) stimulating the Sciatic nerve. The IPG is implanted in the lateral thigh, and the stimulating contacts are oriented perpendicular at the popliteal. The lead code for this patient’s implant is 6-26. *Example 3b: The patient has a Dual 4 Ported IPG (11007-002) with two 40 cm Tined Leads (12005-025).* One lead is stimulating the Axillary nerve and the other is stimulating the Suprascapular nerve. The IPG is implanted on the posterior shoulder over the trapezius. The lead stimulating the Axillary nerve is oriented parallel to the nerve. This lead’s code is 2-09. The lead stimulating the Suprascapular nerve is oriented medial to lateral. This lead’s code is 2-46. Step 4 – Use the Look Up Table After generating a lead code for all implanted leads, use the corresponding Look Up Table to identify the appropriate label for the patient. If the patient has one implanted lead, use the Look Up Table starting on page 24. Look through the first column to find the row that matches the lead code that was generated. The second cell of that row lists the appropriate label code for the patient’s implant. If the patient has two implanted leads, use the Look Up Table starting on page 29. Find the column that corresponds to the lead code generated for the first lead. Then find the row that corresponds to the lead code generated for the second lead. The cell that intersects the identified row and column lists the appropriate label code for the patient’s implant. *Example 4a: The patient has a single implanted lead with lead code 1-05. Using the Look Up Table* starting on page 24, the appropriate label code was identified as LBL-031. *Example 4b: The patient has two implanted leads with lead codes 2-09 and 2-46. Using the Look Up* Table starting on page 29, the appropriate label code was identified as LBL-015. Step 5 – Go to the Identified Label After navigating the Look Up Table and identifying the appropriate label code for the patient’s implant, use the list of Labels starting on page 46 to find the page corresponding to that label code. This page will display the Whole-Body MR Conditionality for the patient’s implant. *Example 5: The appropriate label code for the patient’s implant was identified to be LBL-034. The Whole-* Body MR Conditionality for this patient can be found on page 82. ## For patients with more than one implanted Nalu Neurostimulation System: Repeat Steps 1-5 for each implanted Nalu Neurostimulation System. The MRI examination must adhere to the conditions specified in all applicable labels. The most restrictive SAR value should be used for each specified Zone. Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 12 of 173 --- Device Configurations Device | Device Code | Implanted IPG and Lead | | --- | --- | | 1 | Dual 4 Ported IPG(11007-002)+25cm Tined Lead(12005-025) | | 2 | Dual 4 Ported IPG(11007-002)+40cm Tined Lead(12005-040) | | 3 | Dual 8 Ported IPG(11004-002)+40cm Multilumen Lead(12001-040) | | Dual 8 Integrated IPG,40cm(11002-040) | | | Dual 8 Alternate Pitch IPG(11009-002)+40cm Alternate Pitch Lead(12010-040) | | | 4 | Single 4 Ported IPG(11006-002)+25cm Tined Lead(12005-025) | | Single 4 Integrated IPG,25cm Tined(11005-025) | | | 5 | Single 4 Ported IPG(11006-002)+40cm Tined Lead(12005-040) | | Single 4 Integrated IPG,40cm Tined(11005-040) | | | 6 | Single 8 Ported IPG(11003-002)+40cm Multilumen Lead(12001-040) | | Single 8 Integrated IPG,40cm(11001-040) | | | MR | Any device configuration not listed above is MRI Unsafe. | --- # Nerve Target AXILLARY ... PAGE 15 GENICULAR ... PAGE 16 SAPHENOUS ... PAGE 17 SCIATIC ... PAGE 18 SUPERIOR CLUNEAL ... PAGE 19 SUPRASCAPULAR ... PAGE 20 TIBIAL ... PAGE 21 SCS (SPINAL CORD STIMULATION) ... PAGE 22 SACRAL ... PAGE 23 Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 14 of 173 --- --- Genicular Where is the IPG implanted? 16 What is the orientation of the What is the orientation of the lead’s stimulating contacts? lead’s stimulating contacts? # 10 11 12 13 14 15 MEDIAL LATERAL Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 16 of 173 --- Saphenous Where is the IPG implanted? 23 What is the orientation of the What is the orientation of the What is the orientation of the lead’s stimulating contacts? lead’s stimulating contacts? lead’s stimulating contacts? # 17 18 19 20 21 22 PARALLEL Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 17 of 173 --- --- Superior Cluneal --- --- Tibial --- SCS (Spinal Cord Stimulation) --- Sacral Where is the IPG implanted? 66 What is the orientation of the lead’s stimulating contacts? # 64 65 PARALLEL Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 23 of 173 --- Single Lead Look-Up Table Lead Code Label Code | Lead Code | Label Code | | --- | --- | | 1-01 | LBL-047 | | 1-02 | LBL-051 | | 1-03 | LBL-047 | | 1-04 | LBL-040 | | 1-05 | LBL-031 | | 1-06 | LBL-031 | | 1-07 | LBL-031 | | 1-08 | LBL-031 | | 1-09 | LBL-031 | | 1-10 | LBL-060 | | 1-11 | LBL-002 | | 1-12 | LBL-002 | | 1-13 | LBL-002 | | 1-14 | LBL-002 | | 1-15 | LBL-002 | | 1-16 | LBL-002 | | 1-17 | LBL-001 | | 1-18 | LBL-001 | | 1-19 | LBL-082 | | 1-20 | LBL-082 | | 1-21 | LBL-067 | | 1-22 | LBL-067 | | 1-23 | LBL-067 | | 1-24 | LBL-060 | | 1-25 | LBL-081 | | 1-26 | LBL-058 | | 1-27 | LBL-088 | | 1-28 | LBL-058 | | 1-29 | LBL-073 | | 1-30 | LBL-098 | | 1-31 | LBL-071 | | 1-32 | LBL-099 | | 1-33 | LBL-071 | | 1-34 | LBL-058 | | 1-35 | LBL-001 | | 1-36 | LBL-001 | | 1-37 | LBL-001 | | 1-38 | LBL-001 | | 1-39 | LBL-023 | | 1-40 | LBL-023 | | 1-41 | LBL-023 | | Lead Code | Label Code | | --- | --- | | 1-42 | LBL-020 | | 1-43 | LBL-020 | | 1-44 | LBL-020 | | 1-45 | LBL-025 | | 1-46 | LBL-024 | | 1-47 | LBL-024 | | 1-48 | LBL-020 | | 1-49 | LBL-020 | | 1-50 | LBL-020 | | 1-51 | LBL-020 | | 1-52 | LBL-002 | | 1-53 | LBL-002 | | 1-54 | LBL-002 | | 1-55 | LBL-002 | | 1-56 | LBL-060 | | 1-57 | LBL-060 | | 1-58 | LBL-053 | | 1-59 | LBL-053 | | 1-60 | LBL-002 | | 1-61 | LBL-004 | | 1-62 | LBL-004 | | 1-63 | LBL-004 | | 1-64 | LBL-005 | | 1-65 | LBL-005 | | 1-66 | LBL-005 | | 2-01 | LBL-001 | | 2-02 | LBL-042 | | 2-03 | LBL-042 | | 2-04 | LBL-050 | | 2-05 | LBL-027 | | 2-06 | LBL-027 | | 2-07 | LBL-030 | | 2-08 | LBL-030 | | 2-09 | LBL-027 | | 2-10 | LBL-076 | | 2-11 | LBL-061 | | 2-12 | LBL-061 | | 2-13 | LBL-063 | | 2-14 | LBL-002 | | 2-15 | LBL-002 | | 2-16 | LBL-002 | | 2-17 | LBL-075 | | 2-18 | LBL-075 | | 2-19 | LBL-094 | | 2-20 | LBL-094 | | 2-21 | LBL-077 | | 2-22 | LBL-077 | | 2-23 | LBL-075 | | 2-24 | LBL-106 | | 2-25 | LBL-112 | | 2-26 | LBL-054 | | 2-27 | LBL-001 | | 2-28 | LBL-054 | | 2-29 | LBL-072 | | 2-30 | LBL-097 | | 2-31 | LBL-070 | | 2-32 | LBL-111 | | 2-33 | LBL-070 | | 2-34 | LBL-054 | | 2-35 | LBL-001 | | 2-36 | LBL-113 | | 2-37 | LBL-113 | | 2-38 | LBL-113 | | 2-39 | LBL-010 | | 2-40 | LBL-003 | | 2-41 | LBL-003 | | 2-42 | LBL-003 | | 2-43 | LBL-003 | | 2-44 | LBL-003 | | 2-45 | LBL-018 | | 2-46 | LBL-015 | | 2-47 | LBL-015 | | 2-48 | LBL-037 | | 2-49 | LBL-017 | | 2-50 | LBL-017 | | 2-51 | LBL-003 | | 2-52 | LBL-067 | | 2-53 | LBL-067 | | 2-54 | LBL-057 | | 2-55 | LBL-057 | | 2-56 | LBL-062 | | 2-57 | LBL-062 | | 2-58 | LBL-069 | | Lead Code | Label Code | | --- | --- | | 2-59 | LBL-069 | | 2-60 | LBL-057 | | 2-61 | LBL-004 | | 2-62 | LBL-004 | | 2-63 | LBL-004 | | 2-64 | LBL-005 | | 2-65 | LBL-005 | | 2-66 | LBL-005 | | 3-01 | LBL-001 | | 3-02 | LBL-048 | | 3-03 | LBL-048 | | 3-04 | LBL-001 | | 3-05 | LBL-045 | | 3-06 | LBL-045 | | 3-07 | LBL-041 | | 3-08 | LBL-041 | | 3-09 | LBL-041 | | 3-10 | LBL-086 | | 3-11 | LBL-053 | | 3-12 | LBL-053 | | 3-13 | LBL-065 | | 3-14 | LBL-002 | | 3-15 | LBL-002 | | 3-16 | LBL-002 | | 3-17 | LBL-102 | | 3-18 | LBL-102 | | 3-19 | LBL-110 | | 3-20 | LBL-110 | | 3-21 | LBL-095 | | 3-22 | LBL-095 | | 3-23 | LBL-095 | | 3-24 | LBL-096 | | 3-25 | LBL-001 | | 3-26 | LBL-078 | | 3-27 | LBL-001 | | 3-28 | LBL-078 | | 3-29 | LBL-070 | | 3-30 | LBL-101 | | 3-31 | LBL-092 | | 3-32 | LBL-001 | | 3-33 | LBL-070 | | 3-34 | LBL-070 | | 3-35 | LBL-001 | | 3-36 | LBL-115 | | 3-37 | LBL-115 | | 3-38 | LBL-115 | | 3-39 | LBL-013 | | 3-40 | LBL-011 | | 3-41 | LBL-011 | | 3-42 | LBL-017 | | 3-43 | LBL-003 | | 3-44 | LBL-003 | | 3-45 | LBL-028 | | 3-46 | LBL-022 | | 3-47 | LBL-022 | | 3-48 | LBL-035 | | 3-49 | LBL-021 | | 3-50 | LBL-021 | | 3-51 | LBL-003 | | 3-52 | LBL-063 | | 3-53 | LBL-063 | | 3-54 | LBL-053 | | 3-55 | LBL-053 | | 3-56 | LBL-061 | | 3-57 | LBL-061 | | 3-58 | LBL-068 | | 3-59 | LBL-068 | | 3-60 | LBL-053 | | 3-61 | LBL-116 | | 3-62 | LBL-004 | | 3-63 | LBL-004 | | 3-64 | LBL-005 | | 3-65 | LBL-005 | | 3-66 | LBL-005 | | 4-01 | LBL-044 | | 4-02 | LBL-001 | | 4-03 | LBL-044 | | 4-04 | LBL-032 | | 4-05 | LBL-001 | | 4-06 | LBL-032 | | 4-07 | LBL-032 | | 4-08 | LBL-032 | | 4-09 | LBL-032 | | 4-10 | LBL-002 | | Lead Code | Label Code | | --- | --- | | 4-11 | LBL-002 | | 4-12 | LBL-002 | | 4-13 | LBL-002 | | 4-14 | LBL-002 | | 4-15 | LBL-002 | | 4-16 | LBL-002 | | 4-17 | LBL-001 | | 4-18 | LBL-001 | | 4-19 | LBL-074 | | 4-20 | LBL-074 | | 4-21 | LBL-059 | | 4-22 | LBL-059 | | 4-23 | LBL-059 | | 4-24 | LBL-002 | | 4-25 | LBL-076 | | 4-26 | LBL-059 | | 4-27 | LBL-085 | | 4-28 | LBL-002 | | 4-29 | LBL-066 | | 4-30 | LBL-091 | | 4-31 | LBL-079 | | 4-32 | LBL-088 | | 4-33 | LBL-066 | | 4-34 | LBL-002 | | 4-35 | LBL-001 | | 4-36 | LBL-001 | | 4-37 | LBL-001 | | 4-38 | LBL-001 | | 4-39 | LBL-033 | | 4-40 | LBL-033 | | 4-41 | LBL-033 | | 4-42 | LBL-012 | | 4-43 | LBL-012 | | 4-44 | LBL-012 | | 4-45 | LBL-001 | | 4-46 | LBL-014 | | 4-47 | LBL-014 | | 4-48 | LBL-012 | | 4-49 | LBL-012 | | 4-50 | LBL-012 | | 4-51 | LBL-012 | | 4-52 | LBL-002 | | 4-53 | LBL-002 | | 4-54 | LBL-002 | | 4-55 | LBL-002 | | 4-56 | LBL-052 | | 4-57 | LBL-052 | | 4-58 | LBL-002 | | 4-59 | LBL-002 | | 4-60 | LBL-002 | | 4-61 | LBL-004 | | 4-62 | LBL-004 | | 4-63 | LBL-004 | | 4-64 | LBL-117 | | 4-65 | LBL-005 | | 4-66 | LBL-005 | | 5-01 | LBL-001 | | 5-02 | LBL-046 | | 5-03 | LBL-046 | | 5-04 | LBL-001 | | 5-05 | LBL-026 | | 5-06 | LBL-026 | | 5-07 | LBL-039 | | 5-08 | LBL-039 | | 5-09 | LBL-026 | | 5-10 | LBL-062 | | 5-11 | LBL-063 | | 5-12 | LBL-062 | | 5-13 | LBL-052 | | 5-14 | LBL-054 | | 5-15 | LBL-052 | | 5-16 | LBL-052 | | 5-17 | LBL-083 | | 5-18 | LBL-083 | | 5-19 | LBL-081 | | 5-20 | LBL-081 | | 5-21 | LBL-072 | | 5-22 | LBL-072 | | 5-23 | LBL-072 | | 5-24 | LBL-089 | | 5-25 | LBL-104 | | 5-26 | LBL-056 | | 5-27 | LBL-105 | | 5-28 | LBL-056 | | Lead Code | Label Code | | --- | --- | | 5-29 | LBL-079 | | 5-30 | LBL-090 | | 5-31 | LBL-077 | | 5-32 | LBL-103 | | 5-33 | LBL-077 | | 5-34 | LBL-056 | | 5-35 | LBL-001 | | 5-36 | LBL-114 | | 5-37 | LBL-114 | | 5-38 | LBL-114 | | 5-39 | LBL-019 | | 5-40 | LBL-010 | | 5-41 | LBL-010 | | 5-42 | LBL-003 | | 5-43 | LBL-003 | | 5-44 | LBL-003 | | 5-45 | LBL-017 | | 5-46 | LBL-034 | | 5-47 | LBL-017 | | 5-48 | LBL-029 | | 5-49 | LBL-016 | | 5-50 | LBL-016 | | 5-51 | LBL-003 | | 5-52 | LBL-055 | | 5-53 | LBL-055 | | 5-54 | LBL-058 | | 5-55 | LBL-058 | | 5-56 | LBL-084 | | 5-57 | LBL-084 | | 5-58 | LBL-064 | | 5-59 | LBL-064 | | 5-60 | LBL-055 | | 5-61 | LBL-004 | | 5-62 | LBL-004 | | 5-63 | LBL-004 | | 5-64 | LBL-001 | | 5-65 | LBL-005 | | 5-66 | LBL-005 | | 6-01 | LBL-001 | | 6-02 | LBL-001 | | 6-03 | LBL-001 | | 6-04 | LBL-001 | | 6-05 | LBL-001 | | 6-06 | LBL-001 | | 6-07 | LBL-049 | | 6-08 | LBL-049 | | 6-09 | LBL-049 | | 6-10 | LBL-063 | | 6-11 | LBL-002 | | 6-12 | LBL-002 | | 6-13 | LBL-053 | | 6-14 | LBL-002 | | 6-15 | LBL-002 | | 6-16 | LBL-002 | | 6-17 | LBL-001 | | 6-18 | LBL-001 | | 6-19 | LBL-108 | | 6-20 | LBL-108 | | 6-21 | LBL-107 | | 6-22 | LBL-107 | | 6-23 | LBL-107 | | 6-24 | LBL-093 | | 6-25 | LBL-001 | | 6-26 | LBL-100 | | 6-27 | LBL-001 | | 6-28 | LBL-093 | | 6-29 | LBL-080 | | 6-30 | LBL-109 | | 6-31 | LBL-001 | | 6-32 | LBL-001 | | 6-33 | LBL-080 | | 6-34 | LBL-080 | | 6-35 | LBL-001 | | Lead Code | Label Code | | --- | --- | | 6-36 | LBL-001 | | 6-37 | LBL-001 | | 6-38 | LBL-001 | | 6-39 | LBL-043 | | 6-40 | LBL-031 | | 6-41 | LBL-031 | | 6-42 | LBL-003 | | 6-43 | LBL-003 | | 6-44 | LBL-003 | | 6-45 | LBL-001 | | 6-46 | LBL-034 | | 6-47 | LBL-034 | | 6-48 | LBL-038 | | 6-49 | LBL-036 | | 6-50 | LBL-036 | | 6-51 | LBL-003 | | 6-52 | LBL-054 | | 6-53 | LBL-054 | | 6-54 | LBL-002 | | 6-55 | LBL-002 | | 6-56 | LBL-087 | | 6-57 | LBL-087 | | 6-58 | LBL-060 | | 6-59 | LBL-060 | | 6-60 | LBL-002 | | 6-61 | LBL-004 | | 6-62 | LBL-004 | | 6-63 | LBL-004 | | 6-64 | LBL-005 | | 6-65 | LBL-005 | | 6-66 | LBL-005 | --- # Dual Lead Look-Up Table 1-01 TO 1-33, 1-01 TO 1-33 ... PAGE 30 1-01 TO 1-33, 1-34 TO 1-66 ... PAGE 31 1-34 TO 1-66, 1-01 TO 1-33 ... PAGE 32 1-34 TO 1-66, 1-34 TO 1-66 ... PAGE 33 1-01 TO 1-33, 2-01 TO 2-33 ... PAGE 34 1-01 TO 1-33, 2-34 TO 2-66 ... PAGE 35 1-34 TO 1-66, 2-01 TO 2-33 ... PAGE 36 1-34 TO 1-66, 2-34 TO 2-36 ... PAGE 37 2-01 TO 2-33, 2-01 TO 2-33 ... PAGE 38 2-01 TO 2-33, 2-34 TO 2-66 ... PAGE 39 2-34 TO 2-66, 2-01 TO 2-33 ... PAGE 40 2-34 TO 2-66, 2-34 TO 2-66 ... PAGE 41 3-01 TO 3-33, 3-01 TO 3-33 ... PAGE 42 3-01 TO 3-33, 3-34 TO 3-66 ... PAGE 43 3-34 TO 3-66, 3-01 TO 3-33 ... PAGE 44 3-34 TO 3-66, 3-34 TO 3-66 ... PAGE 45 Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 29 of 173 --- 1-01 to 1-33, 1-01 to 1-33 | | 1.01 | 1.02 | 1.03 | 1.04 | 1.05 | 1.06 | 1.07 | 1.08 | 1.09 | 1.10 | 1.11 | 1.12 | 1.13 | 1.14 | 1.15 | 1.16 | 1.17 | 1.18 | 1.19 | 1.20 | 1.21 | 1.22 | 1.23 | 1.24 | 1.25 | 1.26 | 1.27 | 1.28 | 1.29 | 1.30 | 1.31 | 1.32 | 1.33 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-05 | LRL 037 | LRL 047 | LRL 047 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-02 | LRL 037 | LRL 047 | LRL 047 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-03 | LRL 037 | LRL 047 | LRL 047 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-04 | | | LRL 040 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-05 | | | LRL 031 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-06 | | | LRL 031 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-07 | | | LRL 031 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-08 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-09 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-10 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-11 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- | | 1-34 | 1-35 | 1-36 | 1-37 | 1-38 | 1-39 | 1-40 | 1-41 | 1-42 | 1-43 | 1-44 | 1-45 | 1-46 | 1-47 | 1-48 | 1-49 | 1-50 | 1-51 | 1-52 | 1-53 | 1-54 | 1-55 | 1-56 | 1-57 | 1-58 | 1-59 | 1-60 | 1-61 | 1-62 | 1-63 | 1-64 | 1-65 | 1-66 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-01 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-02 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-03 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-04 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-05 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-07 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-08 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-09 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-10 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-11 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 1-34 to 1-66, 1-01 to 1-33 | | 1-01 | 1-02 | 1-03 | 1-04 | 1-05 | 1-06 | 1-07 | 1-08 | 1-09 | 1-10 | 1-11 | 1-12 | 1-13 | 1-14 | 1-15 | 1-16 | 1-17 | 1-18 | 1-19 | 1-20 | 1-21 | 1-22 | 1-23 | 1-24 | 1-25 | 1-26 | 1-27 | 1-28 | 1-29 | 1-30 | 1-31 | 1-32 | 1-33 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-34 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-35 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-36 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-37 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-38 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-39 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-40 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-41 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-42 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-43 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-44 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 1-34 to 1-66, 1-34 to 1-66 | 1-34 to 1-66 | 1-35 to 1-66 | 1-36 to 1-66 | 1-37 to 1-66 | 1-38 to 1-66 | 1-39 to 1-66 | 1-40 to 1-66 | 1-41 to 1-66 | 1-42 to 1-66 | 1-43 to 1-66 | 1-44 to 1-66 | 1-45 to 1-66 | 1-46 to 1-66 | 1-47 to 1-66 | 1-48 to 1-66 | 1-49 to 1-66 | 1-50 to 1-66 | 1-51 to 1-66 | 1-52 to 1-66 | 1-53 to 1-66 | 1-54 to 1-66 | 1-55 to 1-66 | 1-56 to 1-66 | 1-57 to 1-66 | 1-58 to 1-66 | 1-59 to 1-66 | 1-60 to 1-66 | 1-61 to 1-66 | 1-62 to 1-66 | 1-63 to 1-66 | 1-64 to 1-66 | 1-65 to 1-66 | 1-66 to 1-66 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-34 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | LB.008 | | 1-35 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | | 1-36 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | | 1-37 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | LB.001 | --- 1-01 to 1-33, 2-01 to 2-33 | | 2-05 | 2-02 | 2-03 | 2-04 | 2-05 | 2-06 | 2-07 | 2-08 | 2-09 | 2-10 | 2-11 | 2-12 | 2-13 | 2-14 | 2-15 | 2-16 | 2-17 | 2-18 | 2-19 | 2-20 | 2-21 | 2-22 | 2-23 | 2-24 | 2-25 | 2-26 | 2-27 | 2-28 | 2-29 | 2-30 | 2-31 | 2-32 | 2-33 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-01 | LR. 047 | LR. 042 | LR. 042 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-02 | LR. 051 | LR. 042 | LR. 042 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-03 | LR. 051 | LR. 042 | LR. 042 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-04 | | | LR. 040 | LR. 077 | LR. 077 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-05 | | | LR. 031 | LR. 077 | LR. 077 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-06 | | | LR. 031 | LR. 077 | LR. 077 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-07 | | | | LR. 031 | LR. 077 | LR. 077 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-08 | | | | | LR. 030 | LR. 070 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-09 | | | | | LR. 030 | LR. 070 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-10 | | | | | LR. 030 | LR. 070 | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- | | 2-34 | 2-35 | 2-36 | 2-37 | 2-38 | 2-39 | 2-40 | 2-41 | 2-42 | 2-43 | 2-44 | 2-45 | 2-46 | 2-47 | 2-48 | 2-49 | 2-50 | 2-51 | 2-52 | 2-53 | 2-54 | 2-55 | 2-56 | 2-57 | 2-58 | 2-59 | 2-60 | 2-61 | 2-62 | 2-63 | 2-64 | 2-65 | 2-66 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-01 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-02 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-03 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-04 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-05 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-07 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-08 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-09 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-10 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-11 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 1-34 to 1-66, 2-01 to 2-33 | | 2-01 | 2-02 | 2-03 | 2-04 | 2-05 | 2-06 | 2-07 | 2-08 | 2-09 | 2-10 | 2-11 | 2-12 | 2-13 | 2-14 | 2-15 | 2-16 | 2-17 | 2-18 | 2-19 | 2-20 | 2-21 | 2-22 | 2-23 | 2-24 | 2-25 | 2-26 | 2-27 | 2-28 | 2-29 | 2-30 | 2-31 | 2-32 | 2-33 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-34 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-35 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-36 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-37 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-38 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-39 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-40 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-41 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-42 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-43 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 1-44 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 1-34 to 1-66, 2-34 to 2-36 | | 2-34 | 2-35 | 2-36 | 2-37 | 2-38 | 2-39 | 2-40 | 2-41 | 2-42 | 2-43 | 2-44 | 2-45 | 2-46 | 2-47 | 2-48 | 2-49 | 2-50 | 2-51 | 2-52 | 2-53 | 2-54 | 2-55 | 2-56 | 2-57 | 2-58 | 2-59 | 2-60 | 2-61 | 2-62 | 2-63 | 2-64 | 2-65 | 2-66 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 1-34 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | | | 1-35 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | | | | 1-36 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | | | | | 1-37 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | LB/LC 004 | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 2-01 to 2-33, 2-01 to 2-33 | | 2-01 | 2-02 | 2-03 | 2-04 | 2-05 | 2-06 | 2-07 | 2-08 | 2-09 | 2-10 | 2-11 | 2-12 | 2-13 | 2-14 | 2-15 | 2-16 | 2-17 | 2-18 | 2-19 | 2-20 | 2-21 | 2-22 | 2-23 | 2-24 | 2-25 | 2-26 | 2-27 | 2-28 | 2-29 | 2-30 | 2-31 | 2-32 | 2-33 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 2-01 | LB. 001 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | | 2-03 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | LB. 042 | | | 2-04 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | | | 2-05 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | LB. 027 | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- | | 2-34 | 2-35 | 2-36 | 2-37 | 2-38 | 2-39 | 2-40 | 2-41 | 2-42 | 2-43 | 2-44 | 2-45 | 2-46 | 2-47 | 2-48 | 2-49 | 2-50 | 2-51 | 2-52 | 2-53 | 2-54 | 2-55 | 2-56 | 2-57 | 2-58 | 2-59 | 2-60 | 2-61 | 2-62 | 2-63 | 2-64 | 2-65 | 2-66 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 2-01 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-02 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-03 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-04 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-05 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-07 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-08 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-09 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-10 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-11 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 2-34 to 2-66, 2-01 to 2-33 | | 2-01 | 2-02 | 2-03 | 2-04 | 2-05 | 2-06 | 2-07 | 2-08 | 2-09 | 2-10 | 2-11 | 2-12 | 2-13 | 2-14 | 2-15 | 2-16 | 2-17 | 2-18 | 2-19 | 2-20 | 2-21 | 2-22 | 2-23 | 2-24 | 2-25 | 2-26 | 2-27 | 2-28 | 2-29 | 2-30 | 2-31 | 2-32 | 2-33 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 2-34 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-35 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-36 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-37 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-38 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-39 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-40 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-41 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-42 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-43 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-44 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 2-34 to 2-66, 2-34 to 2-66 | | 2-34 | 2-35 | 2-36 | 2-37 | 2-38 | 2-39 | 2-40 | 2-41 | 2-42 | 2-43 | 2-44 | 2-45 | 2-46 | 2-47 | 2-48 | 2-49 | 2-50 | 2-51 | 2-52 | 2-53 | 2-54 | 2-55 | 2-56 | 2-57 | 2-58 | 2-59 | 2-60 | 2-61 | 2-62 | 2-63 | 2-64 | 2-65 | 2-66 | | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 2-34 | LB-004 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-35 | LB-002 | LB-001 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | | 2-36 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | | | 2-37 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | LB-113 | | | 2-38 | LB-113 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 2-39 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 3-01 to 3-33, 3-01 to 3-33 | | 3-01 | 3-02 | 3-03 | 3-04 | 3-05 | 3-06 | 3-07 | 3-08 | 3-09 | 3-10 | 3-11 | 3-12 | 3-13 | 3-14 | 3-15 | 3-16 | 3-17 | 3-18 | 3-19 | 3-20 | 3-21 | 3-22 | 3-23 | 3-24 | 3-25 | 3-26 | 3-27 | 3-28 | 3-29 | 3-30 | 3-31 | 3-32 | 3-33 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3-01 | LB. 001 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | | | 3-02 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | | | | 3-03 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | LB. 048 | | | | | 3-04 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-05 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-07 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 3-01 to 3-33, 3-34 to 3-66 | | 3-34 | 3-35 | 3-36 | 3-37 | 3-38 | 3-39 | 3-40 | 3-41 | 3-42 | 3-43 | 3-44 | 3-45 | 3-46 | 3-47 | 3-48 | 3-49 | 3-50 | 3-51 | 3-52 | 3-53 | 3-54 | 3-55 | 3-56 | 3-57 | 3-58 | 3-59 | 3-60 | 3-61 | 3-62 | 3-63 | 3-64 | 3-65 | 3-66 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3-01 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-02 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-03 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-04 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-05 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-06 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-07 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-08 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-09 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-10 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-11 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 3-34 to 3-66, 3-01 to 3-33 | | 3-01 | 3-02 | 3-03 | 3-04 | 3-05 | 3-06 | 3-07 | 3-08 | 3-09 | 3-10 | 3-11 | 3-12 | 3-13 | 3-14 | 3-15 | 3-16 | 3-17 | 3-18 | 3-19 | 3-20 | 3-21 | 3-22 | 3-23 | 3-24 | 3-25 | 3-26 | 3-27 | 3-28 | 3-29 | 3-30 | 3-31 | 3-32 | 3-33 | | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3-34 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-35 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-36 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-37 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-38 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-39 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-40 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-41 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-42 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-43 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | 3-44 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A --- 3-34 to 3-66, 3-34 to 3-66 | | 3-34 | 3-35 | 3-36 | 3-37 | 3-38 | 3-39 | 3-40 | 3-41 | 3-42 | 3-43 | 3-44 | 3-45 | 3-46 | 3-47 | 3-48 | 3-49 | 3-50 | 3-51 | 3-52 | 3-53 | 3-54 | 3-55 | 3-56 | 3-57 | 3-58 | 3-59 | 3-60 | 3-61 | 3-62 | 3-63 | 3-64 | 3-65 | 3-66 | | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | | 3-34LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | LR09 | | | | 3-35LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | | | | | 3-36LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | LR15 | | | | | --- # Labels *LBL-001 ... 49* *LBL-002 ... 50* *LBL-003 ... 51* *LBL-004 ... 52* *LBL-005 ... 53* *LBL-006 ... 54* *LBL-007 ... 55* *LBL-008 ... 56* *LBL-009 ... 57* *LBL-010 ... 58* *LBL-011 ... 59* *LBL-012 ... 60* *LBL-013 ... 61* *LBL-014 ... 62* *LBL-015 ... 63* *LBL-016 ... 64* *LBL-017 ... 65* *LBL-018 ... 66* *LBL-019 ... 67* *LBL-020 ... 68* *LBL-021 ... 69* *LBL-022 ... 70* *LBL-023 ... 71* *LBL-024 ... 72* *LBL-025 ... 73* *LBL-026 ... 74* *LBL-027 ... 75* *LBL-028 ... 76* *LBL-029 ... 77* *LBL-030 ... 78* *LBL-031 ... 79* *LBL-032 ... 80* *LBL-033 ... 81* *LBL-034 ... 82* *LBL-035 ... 83* *LBL-036 ... 84* *LBL-037 ... 85* *LBL-038 ... 86* *LBL-039 ... 87* *LBL-040 ... 88* *LBL-041 ... 89* *LBL-042 ... 90* *LBL-043 ... 91* *LBL-044 ... 92* *LBL-045 ... 93* *LBL-046 ... 94* *LBL-047 ... 95* Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 46 of 173 --- *LBL-048 ... 96* *LBL-049 ... 97* *LBL-050 ... 98* *LBL-051 ... 99* *LBL-052 ... 100* *LBL-053 ... 101* *LBL-054 ... 102* *LBL-055 ... 103* *LBL-056 ... 104* *LBL-057 ... 105* *LBL-058 ... 106* *LBL-059 ... 107* *LBL-060 ... 108* *LBL-061 ... 109* *LBL-062 ... 110* *LBL-063 ... 111* *LBL-064 ... 112* *LBL-065 ... 113* *LBL-066 ... 114* *LBL-067 ... 115* *LBL-068 ... 116* *LBL-069 ... 117* *LBL-070 ... 118* *LBL-071 ... 119* *LBL-072 ... 120* *LBL-073 ... 121* *LBL-074 ... 122* *LBL-075 ... 123* *LBL-076 ... 124* *LBL-077 ... 125* *LBL-078 ... 126* *LBL-079 ... 127* *LBL-080 ... 128* *LBL-081 ... 129* *LBL-082 ... 130* *LBL-083 ... 131* *LBL-084 ... 132* *LBL-085 ... 133* *LBL-086 ... 134* *LBL-087 ... 135* *LBL-088 ... 136* *LBL-089 ... 137* *LBL-090 ... 138* *LBL-091 ... 139* *LBL-092 ... 140* *LBL-093 ... 141* *LBL-094 ... 142* *LBL-095 ... 143* *LBL-096 ... 144* Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 47 of 173 --- *LBL-097 ... 145* *LBL-098 ... 146* *LBL-099 ... 147* *LBL-100 ... 148* *LBL-101 ... 149* *LBL-102 ... 150* *LBL-103 ... 151* *LBL-104 ... 152* *LBL-105 ... 153* *LBL-106 ... 154* *LBL-107 ... 155* *LBL-108 ... 156* *LBL-109 ... 157* *LBL-110 ... 158* *LBL-111 ... 159* *LBL-112 ... 160* *LBL-113 ... 161* *LBL-114 ... 162* *LBL-115 ... 163* *LBL-116 ... 164* *LBL-117 ... 165* *LBL-118 ... 166* *LBL-119 ... 167* *LBL-120 ... 168* *LBL-121 ... 169* *LBL-122 ... 170* *LBL-123 ... 171* Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 48 of 173 --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu Neurostimulation System may be safely scanned anywhere in the body at 1.5 T under the following conditions. Failure to follow these conditions may result in injury. NOTE: This label is only applicable to certain lead codes and/or lead code combinations. Refer to the guide on page 11 for directions on how to generate a patient’s lead code and corresponding MR Conditionality. Parameter Condition | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_{0}$) | 1.5 T | | MR Scanner Type | Cylindrical | | $B_{0}$ Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20 T/m(2000 gauss/cm) | | Maximum Gradient Slew Rate | 200 T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Volume Body RF Coil | | Receive Coil Type | Any | | RF Conditions | Normal Operating Mode(Whole-Body SAR≤2W/kg) | | Scan Duration | Scan for up to 30 minutes, wait 30 minutes for the next imaging session. | | Scan Regions | Any landmark is acceptable | | Image Artifact | In non-clinical testing,the image artifact caused by the Nalu Neurostimulation System extends approximately10mm from this implant when imaged using a gradient echo pulse sequence and a3T MRI system. | \underline({B_{0}}) Important Note: An MRI examination performed outside these guidelines may cause the electromagnetic fields used with MRI technology to interact adversely with an implanted Nalu Neurostimulation System potentially injuring the patient and/or damaging the device. Due to the risks of using MRI in a patient with an active implanted device, it is important to read, understand, and comply with all instructions to prevent potential harm or injury to the patient and/or damage to the device. B_{0} --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu Neurostimulation System may be safely scanned anywhere in the body at 1.5 T under the following conditions. Failure to follow these conditions may result in injury. NOTE: This label is only applicable to certain implant codes and/or implant code combinations. Refer to the guide on page 11 for directions on how to generate a patient’s implant code and corresponding MR Conditionality. Parameter Condition | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_0$) | 1.5T | | MR Scanner Type | Cylindrical | | $B_0$Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20T/m(2000gauss/cm) | | Maximum Gradient Slew Rate | 200T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Volume Body RF Coil | | Receive Coil Type | Any | | RF Conditions | For ZoneA:Normal Operating Mode(Whole-BodySAR≤2W/kg) | | For ZoneB:MR Unsafe,do not scan in this region | | | Scan Duration | Scan for up to30minutes,wait 30 minutes for the next imaging session. | | Scan Regions | Any landmark is acceptable | | Image Artifact | In non-clinical testing,the image artifact caused by the Nalu Neurostimulation System extends approximately10mm from this implant when imaged using a gradient echo pulse sequence and a3TMRI system. | \underline({B_{0}}) B_{0} Figure 2 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_{0}$) | 1.5 T | | MR Scanner Type | Cylindrical | | $B_{0}$Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20 T/m(2000 gauss/cm) | | Maximum Gradient Slew Rate | 200 T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Volume Body RF Coil | | Receive Coil Type | Any | | RF Conditions | For Zone A:Normal Operating Mode(Whole-Body SAR≤2W/kg) | | For Zone B:MR Unsafe,do not scan in this region | | | Scan Duration | Scan for up to 30 minutes,wait 30 minutes for the next imaging session. | | Scan Regions | Any landmark is acceptable | | Image Artifact | In non-clinical testing,the image artifact caused by the Nalu Neurostimulation System extends approximately10mm from this implant when imaged using a gradient echo pulse sequence and a3T MRI system. | \underline({B_{0}}) B_{0} Figure 3 Zone B: from top of head, to the top of femur Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_{0}$) | 1.5T | | MR Scanner Type | Cylindrical | | $B_{0}$Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20 T/m(2000 gauss/cm) | | Maximum Gradient Slew Rate | 200 T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Volume Body RF Coil | | Receive Coil Type | Any | | RF Conditions | For Zone A:Normal Operating Mode(Whole-Body SAR≤2W/kg) | | For Zone B:MR Unsafe,do not scan in this region | | | Scan Duration | Scan for up to 30 minutes,wait 30 minutes for the next imaging session. | | Scan Regions | Any landmark is acceptable | | Image Artifact | In non-clinical testing,the image artifact caused by the Nalu Neurostimulation System extends approximately10mm from this implant when imaged using a gradient echo pulse sequence and a3T MRI system. | \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae C1 | | | --- | --- | | Zone B: from vertebrae C1, to vertebrae L2 | | | Zone A: from vertebrae L2, to the bottom of foot | | Figure 4 (1,1 --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae T4 | | | --- | --- | | Zone B: from vertebrae T4, to mid femur | | | Zone A: from mid femur, to the bottom of foot | | Figure 5 --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_{0}$) | 1.5T | | MR Scanner Type | Cylindrical | | $B_{0}$Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20T/m(2000gauss/cm) | | Maximum Gradient Slew Rate | 200T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Volume Body RF Coil | | Receive Coil Type | Any | | RF Conditions | For ZoneA:Normal Operating Mode(Whole-BodySAR≤2W/kg) | | For ZoneB:MR Unsafe,do not scan in this region | | | Scan Duration | Scan for up to30minutes,wait30 minutes for the next imaging session. | | Scan Regions | Any landmark is acceptable | | Image Artifact | In non-clinical testing,the image artifact caused by the Nalu Neurostimulation System extends approximately10mm from this implant when imaged using a gradient echo pulse sequence and a3TMRI system. | \underline({B_{0}}) B_{0} Zone B: from top of head, to mid femur Figure 6 Zone A: from mid femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae C1 | | | --- | --- | | Zone B: from vertebrae C1, to mid femur | | | Zone A: from mid femur, to the bottom of foot | | Figure 7 --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 8 --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to mid femur Figure 9 Zone A: from mid femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 10 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu For Whole-Body MR Examinations: A person implanted with the Nalu Neurostimulation System may be safely scanned anywhere in the body at 1.5 T under the following conditions. Failure to follow these conditions may result in injury. NOTE: This label is only applicable to certain implant codes and/or implant code combinations. Refer to the guide on page 11 for directions on how to generate a patient’s implant code and corresponding MR Conditionality. Parameter Condition \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 11 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 12 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 13 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 14 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 15 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 16 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 17 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 18 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 19 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 20 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 21 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 22 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \left(B_{0}\right) \underline{{B_{0}}} Zone B: from top of head, to the top of femur Figure 23 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 24 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 25 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 26 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 27 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 28 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 29 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 30 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \left(B_{0}\right) \underline{{B_{0}}} Zone B: from top of head, to the top of femur Figure 31 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 32 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 33 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 34 Zone B: from top of head, to the top of femur Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 35 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 36 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 37 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 38 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 39 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 40 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 41 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 42 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 43 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 44 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 45 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 46 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 47 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 48 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 49 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 50 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to the top of femur Figure 51 Zone A: from top of femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 52 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 53 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 54 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 55 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 56 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 57 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 58 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 59 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 60 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 61 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 62 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_0$) | 1.5 T | | MR Scanner Type | Cylindrical | | $B_0$ Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20 T/m(2000 gauss/cm) | | Maximum Gradient Slew Rate | 200 T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Volume Body RF Coil | | Receive Coil Type | Any | | RF Conditions | For Zone A:Normal Operating Mode(Whole-Body SAR≤2W/kg) | | For Zone B:MR Unsafe,do not scan in this region | | | Scan Duration | Scan for up to 30 minutes,wait 30 minutes for the next imaging session. | | Scan Regions | Any landmark is acceptable | | Image Artifact | In non-clinical testing,the image artifact caused by the Nalu Neurostimulation System extends approximately10mm from this implant when imaged using a gradient echo pulse sequence and a3T MRI system. | \underline({B_{0}}) B_{0} Figure 63 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 64 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 65 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 66 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 67 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 68 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 69 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 70 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 71 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 72 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 73 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 74 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 75 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 76 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 77 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 78 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 79 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 80 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu | Parameter | Condition | | --- | --- | | Device Name | Nalu Neurostimulation System | | Device Configuration | Stimulation OFF, no external devices | | Static Magnetic Field Strength ($B_0$) | 1.5 T | | MR Scanner Type | Cylindrical | | $B_0$ Field Orientation | Horizontal | | Maximum Spatial Field Gradient | 20 T/m (2000 gauss/cm) | | Maximum Gradient Slew Rate | 200 T/m/s per axis | | RF Excitation | Circularly Polarized(CP) | | RF Transmit Coil Type | Volume Body RF Coil | | Receive Coil Type | Any | | RF Conditions | For Zone A: Normal Operating Mode(Whole-Body SAR≤2W/kg) | | For Zone B: MR Unsafe, do not scan in this region | | | Scan Duration | Scan for up to 30 minutes, wait 30 minutes for the next imaging session. | | Scan Regions | Any landmark is acceptable | | Image Artifact | In non-clinical testing,the image artifact caused by the Nalu Neurostimulation System extends approximately10mm from this implant when imaged using a gradient echo pulse sequence and a3T MRI system. | \underline({B_{0}}) B_{0} Figure 81 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 82 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 83 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 84 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 85 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 86 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 87 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 88 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 89 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 90 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 91 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 92 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 93 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 94 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline{{B_{0}}} Figure 95 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 96 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 97 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 98 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 99 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 100 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 101 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 102 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 103 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 104 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 105 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 106 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 107 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 108 Zone B: from the vertebrae L4, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 109 Zone B: from the vertebrae L4, to the bottom of foot --- LBL-110 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 110 Zone B: from the vertebrae L4, to the bottom of foot --- LBL-111 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 111 Zone B: from the vertebrae L4, to the bottom of foot --- LBL-112 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Figure 112 Zone B: from the vertebrae L4, to the bottom of foot --- LBL-113 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae L3 | | | --- | --- | | Zone B: from vertebrae L3, to the mid femur | | | Zone A: from mid femur, to the bottom of foot | | Figure 113 --- LBL-114 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae L3 | | --- | | Zone B: from vertebrae L3, to the mid femur | | Zone A: from mid femur, to the bottom of foot | Figure 114 --- LBL-115 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae L3 | | --- | | Zone B: from vertebrae L3, to the mid femur | | Zone A: from mid femur, to the bottom of foot | Figure 115 --- LBL-116 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae C1 | | --- | | Zone B: from vertebrae C1, to vertebrae L2 | | Zone A: from vertebrae L2, to the bottom of foot | Figure 116 --- LBL-117 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to vertebrae C1 | | | --- | --- | | Zone B: from vertebrae C1, to vertebrae L2 | | | Zone A: from vertebrae L2, to the bottom of foot | | Figure 117 --- LBL-118 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to mid femur Figure 118 Zone A: from mid femur, to the bottom of foot --- LBL-119 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to mid femur Figure 119 Zone A: from mid femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to mid femur Figure 120 Zone A: from mid femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} | Zone A: from top of head, to the vertebrae C1 | | --- | | Zone B: from vertebrae C1, to mid femur | | Zone A: from mid femur, to the bottom of foot | Figure 121 --- LBL-122 MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to mid femur Figure 122 Zone A: from mid femur, to the bottom of foot --- MR Conditional MRI Safety Information For Whole-Body MR Examinations: A person implanted with the Nalu \underline({B_{0}}) B_{0} Zone B: from top of head, to mid femur Figure 123 Zone A: from mid femur, to the bottom of foot --- # APPENDIX A ## Whole-Body MRI Quick Reference Guide Nalu Neurostimulation System Magnetic Resonance Imaging (MRI) Safety Information-PN: MA-000105 Rev A Page 172 of 173 --- CONTACT INFORMATION Nalu Medical, Inc. 2320 Faraday Ave Ste 100 Carlsbad, CA 92008 USA Telephone: +1-800-618-3402 Customer Service: info@nalumed.com Technical Support: support@nalumed.com www.nalumed.com This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. Caution: Federal law restricts this device to sale by or on the order of a physician Nalu is a trademark of Nalu Medical Inc. Bluetooth is a registered trademark of Bluetooth®sig, Inc.