MA 000105 Rev A.pdf
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-
- 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.