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RNS System User Manual

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1. Model CT 01 K Model P 01 K Item Model Number Item Model Number Craniectomy Template CT 01 Cranial Prosthesis P 01 Lead Strain Relief LSR 01 Ferrule Clamp FC 01 Torque Driver TD 01 Torque Driver TD 01 Connector Cover Kit Ferrule Kit Model CC 01 K Model F 01 K Item Model Number Item Model Number Connector Cover CC 01 Ferrule F 01 Connector Plugs 2 CP 01 Ferrule Clamp FC 01 Lead Strain Relief LSR 01 Torque Driver TD 01 Torque Driver TD 01 RNS System User Manual Item Model Number Magnet M 01 Glossary 101 GLOSSARY Adaptive Adaptive is an advanced responsive therapy setting The Adaptive specifies a ratio of the pulse to pulse interval of the stimulation to the sensed signal period Adapt channel The adapt channel is an advanced responsive therapy setting The Neurostimulator will monitor this channel from which to calculate the adaptive stimulation frequency This channel is used for all adaptive bursts Adaptive Default Frequency The Adaptive Default Frequency is an advanced setting available for each responsive therapy burst For an adaptive therapy burst Adaptive Frequency ON if the calculated stimulation frequency does not fall between the programmed Min and Max Frequencies then the stimulation is delivered at the Adaptive Default Frequency Adaptive Max Frequency The Adaptive Max Frequency is an advanced setting a
2. 2 Before placing the insertion cannula onto the frame insert the Depth Lead into the insertion cannula and place the Stop Gauge provided on the Lead directly above the cannula such that the lead tip will reach the implant target after the lead is fully advanced down the cannula The Stop Gauge should meet the top of the cannula once the lead is advanced the desired distance Figure 8 Lead stop gauge Insertion cannula Lead Depth lead tip Stylet retainer Figure 8 Position the Stop Gauge directly above the insertion cannula in order to gauge the full insertion distance of the Depth Lead 3 Retract the Lead with stylet and Stop Gauge intact from the insertion cannula and set the Lead aside 4 Attach the insertion cannula to the frame Using standard surgical techniques prepare the neural tissue for the Depth Lead implant 6 Advance the insertion cannula to the desired depth with the insertion cannula stylet in place to seal the insertion cannula lumen Then remove the insertion cannula stylet and insert the Depth Lead with the Lead stylet and Stop Gauge in place into the insertion cannula Precaution Lead Damage Bending kinking and stretching of the Lead may cause Lead damage Handle the Lead with care 7 Advance the Lead into the neural tissue until the Stop Gauge has reached the top of the insertion cannula 8 Verify that the Lead is in the desired anatomical position Depth Lead Stabilization 1
3. 9 Change stimulation parameters as desired and select the DELIVER button to initiate a Test Stimulation When Test Stimulation is complete select ACCEPT CHANGES and the current settings will now be reflected on the THERAPY tab or select CANCEL CHANGES to return to the THERAPY tab with the original settings 10 Select RESPONSIVE THERAPY to be ENABLED Recommended Initial Responsive Therapy Settings Stimulation may be programmed ON when appropriate detection settings have been established Stimulation should be tested to ensure patient tolerability before enabling responsive stimulation e Test Stimulation e Stimulation may evoke visual olfactory auditory taste sensory or motor responses e Test stimulations should be delivered to each electrode individually electrode to can to determine whether there are acute side effects from stimulation e Habituation to side effects resulting from stimulation has been observed however it is not advised to program settings that cause patient discomfort e Avoid stimulation settings that cause an electrographic afterdischarge Note Test stimulation can be performed from the TEST STIMULATION screen or by selecting the THERAPY TESTING button from within the RESPONSIVE THERAPY screens The latter method allows the user to copy the tested settings back to the RESPONSIVE THERAPY screens for easier programming Precaution Afterdischarge Activity If evidence of afterdischarge activity resultin
4. 84 88 101 Bone screws 35 Burr hole 37 101 C Candidates for the RNS System 29 Case Damage 12 Charge density 102 Chronic Tissue Stimulation 11 Clinical Use 29 Commanded measurements 56 Computerized tomography CT 14 Computerized Tomography CT 86 Configuring Detection 30 32 69 70 Connector Cover 22 102 Connector Plug 22 47 51 53 102 Connector port 102 Contacting NeuroPace 5 Contraindications 9 Cortical Strip Lead 102 Abandonment 52 Components and Accessories 24 Description 23 Handling 26 Implantation 30 40 Montage 60 85 104 Replacement 52 Specifications 91 Cortical Strip Lead Explantation 10 Cranial Prosthesis 22 51 102 Cranial Tunneling Tool See Tunneling Tool Craniectomy 41 102 Craniectomy template 22 102 RNS System User Manual D Damaged packaging 26 34 Damaged products 84 DC Leak 88 Defibrillator 17 Depth Lead 102 Abandonment 52 Components and Accessories 24 Description 23 Handling 26 Implantation 30 37 Montage 60 85 104 Replacement 52 Specifications 91 Detection Settings 30 32 69 70 Detector 72 DetectorArea 71 DetectorLine Length 70 Diagnostic information 81 Diagnostic summary 105 Diathermy Contraindication 9 Disabling stimulation 76 Disposal of product 26 E ECoG 102 Artifact 63 86 Capturing See ECoG Storage See ECoG Storage Real time 33 56 59 63 83 86 104 Records 56 57 83 Retrieving 57 Stor
5. The NeuroPace RNS Neurostimulator NeuroPace Cortical Strip Lead and NeuroPace Depth Lead are not compatible with non NeuroPace leads and or pulse generators Incompatible configurations may cause damage to the products and may result in unsafe current densities delivered to the patient LEAD COMPONENT AND ACCESSORIES Tunneling Tool Model TT 01 Tunneling Tool Tip Model TTT 01 Tunneling Straw Model TTS 01 The Tunneling Tool components are used to tunnel an implanted Lead from its cranial exit point through a sub galeal pathway to the implanted RNS Neurostimulator location Lead Cap Model LC 01 The Lead Cap protects the proximal end of a Lead when it is not connected to the RNS Neurostimulator Stop Gauge Model SG 01 The Stop Gauge is placed on a Depth Lead prior to implantation to indicate the appropriate depth of its insertion Suture Sleeve Model SS 01 The Suture Sleeves protect the Lead body when sutures are used to secure a Lead NEUROPACE PROGRAMMER NeuroPace Programmer Model PGM 300 The Programmer includes a laptop personal computer that runs software developed by NeuroPace and uses custom telemetry components to communicate with the RNS Neurostimulator The Programmer is used to prescribe how the Neurostimulator operates Settings include but are not limited to the implanted system configuration detection settings adapted to the patient s ECoG patterns ECoG record storage and the settings
6. under REVIEW DATA tab and measure Lead impedance s under MEASUREMENTS tab to ensure proper connection between the Neurostimulator and the Leads An acceptable range for Lead impedance is 250 3500 ohms If impedance measurements are abnormal or real time ECoG signals are not adequate remove the Connector Cover and flush the connector area Fully reinsert the leads into the Connector Cover and repeat the impedance measurements Refer to the Troubleshooting section if impedance measurements remain abnormal Use the Lead Caps provided to cap the proximal ends of any unconnected leads Secure the Lead Caps with a suture if desired Situate all capped unconnected Leads adjacent to the Neurostimulator to facilitate easy connection to the Neurostimulator in the future Place any excess Lead length in a sub galeal pocket near the craniectomy away from the incision line Close the incision After the incision closure interrogate the Neurostimulator again using the Programmer Confirm that the impedance measurements and real time ECoG signals are normal Note It is common for the Neurostimulator to reset if electrocautery is used near the Neurostimulator or Leads To recover from a Neurostimulator reset perform the following 1 Document all error messages Proceed with the interrogation Go to the PROGRAM SETTINGS tab and select Program Synchronize the Programmer with PDMS post operatively If problems persist refer to the Trou
7. 89 Actions to be Taken 1 Select CONTINUE e The Programmer collects additional information and displays various messages such as Gather Information Working RAM e The Programmer then displays the message To recover from the reset condition continue the interrogation and then program the Neurostimulator Synchronize Programmer with PDMS and contact NeuroPace 2 Select CONTINUE e The Programmer interrogates the Neurostimulator including uploading of any stored ECoGs The Programmer then displays the SUMMARY tab 3 Select the PROGRAM SETTINGS tab and select PROGRAM e The Programmer may display the message The Neurostimulator contains ECoGs that have not been uploaded to the Programmer Continuing will delete the ECoG data from the Neurostimulator Cancel and Interrogate to upload the ECoGs Note Any stored ECoGs were already uploaded to the Programmer but they remain stored on the Neurostimulator because of the reset 4 Select CONTINUE if necessary e The Neurostimulator is now programmed to the state it was in before the reset occurred 5 Ifthe reset persistently reoccurs in the absence of any surgical procedures the Neurostimulator may be defective Contact NeuroPace for further assistance RNS System User Manual Specifications 90 SPECIFICATIONS RNS NEUROSTIMULATOR SPECIFICATIONS RNS Neurostimulator Specifications WIDTH 28 mm 42 mm including Lead Strain Relief THICKNESS 7 7mm
8. Default Line Length 75 on Ch 1 amp 3 Mon Apr 30 2007 14 10 08 Pacific Daylight Time GMT 7 Default Line Length 75 on Ch 1 Current Detection Set une Length 75 on Ch 1 amp 3 Generate Name Time Mon Apr 30 2007 14 12 06 Description i A Ch 1 Line Length 75 0 Pattern B Ch 3 Line Length 75 0 Generate Description Select detector channels Pattern A Bandpass Off First Detector Channel 1 LHipl LHip2 Detect on LHip1 LHip2 Line Length On Percentage Second Detector Channel 3 RHipl RHip2 Area Off Bandpass Detect on RHip1 RHip2 Line Length rea 0 Pattern B Bandpass Off Detect on LHip1 LHip2 Line Length Off Area Off Bandpass Off Off Detect on RHip1 RHip2 Line Length On Percentage Area Settings Selection Mode Clinical Detection Status Enabled Figure 28 Detectors tab Recommended Modifications to Detection Settings After initial ECoGs have been stored the physician should review the stored ECoGs and identify the specific electrocorticographic patterns to be detected Based on the type of pattern to be detected the physician can program the Neurostimulator to use 1 of 3 programmable detection tools detectors Three detector types are available these are the Line Length Area and Bandpass The detector type should be selected based on the type of pattern to be detected Line Length detector The Line Length detector works by measuring the total l
9. If necessary 5 mm or 7 mm long bone screws may be used If the 1 5 mm diameter screws do not securely anchor the Ferrule in the skull 1 8 mm diameter screws should be used RNS System User Manual Surgical Procedures 36 RECOMMENDED IMPLANT PROCEDURE FLOW CHART Depth Lead Implant Cortical Strip Lead Implant Make Burr Hole at appropriate location to implant Depth Lead v Attach Burr Hole Cover base to skull Neurostimulator Implant Perform appropriate craniotomy to implant Cortical Strip Lead y Make scalp incision at the desired implant location Advance insertion cannula to appropriate depth R4 v Separate and resect dura L4 Trace the Craniectomy Template on the skull at the implant location Advance Depth Lead to target depth wv v Implant Cortical Strip Lead subdurally v Make craniectomy around template drawing Secure Depth Lead using Burr Hole Cover Cap v v Stabilize Cortical Strip Lead using Suture Sleeves as appropriate Secure the Ferrule in the craniectomy Tunnel Leads to Neurostimulator v Place the excess Lead under the scalp in a pocket area near the burr hole or craniectomy area Do not place the Leads on or around the Neurostimulator Insert the Lead s into the Connector Cover and secure the cover
10. Magnet N NI Sensing Digital Processing Patient Patient Lead s V and Analysis Microprocessor Digital Storage and Retrieval Lead s Neurostimulator Figure 3 The RNS Neurostimulator senses and delivers therapy via the implanted patient Leads Communication with the Neurostimulator is available using the Programmer and Remote Monitor RNS System User Manual Responsive Neurostimulator System 22 RNS NEUROSTIMULATOR RNS Neurostimulator Model RNS 300M The NeuroPace RNS Neurostimulator is a responsive electrical stimulation medical device The Neurostimulator senses and records electrocorticographic ECoG patterns from up to four amplifier channels Upon detection of previously identified ECoG patterns the Neurostimulator delivers short trains of current pulses through the Leads to interrupt those ECoG patterns This is referred to as responsive electrical stimulation The RNS Neurostimulator is a battery powered microprocessor controlled medical device that is surgically implanted in the cranium and is covered by the scalp The Neurostimulator is connected to one or two Leads that are surgically implanted within Depth Lead or on the surface Cortical Strip Lead of the brain in the area of the epileptic seizure focus Each Lead contains four electrodes that can be assigned to one or two of four amplifier channels The RNS Neurostimulator can be programmed to monitor and deliver re
11. NeuroPace Depth Lead Kit Models DL 330 3 5 K DL 330 10 K DL 344 3 5 K and DL 344 10 K Item Model Number NeuroPace Depth Lead DL 330 3 5 DL 330 10 DL 344 3 5 DL 344 10 Lead Cap 2 LC 01 Stop Gauge SG 01 Suture Sleeves 4 SS 01 Tunneling Tool Straw TTS 01 NeuroPace Cortical Strip Lead Kit Models CL 315 10 K CL 325 10 K and CL 335 10 K Item Model Number NeuroPace Cortical Strip Lead CL 315 10 CL 325 10 CL 335 10 Lead Cap 2 LC 01 Suture Sleeves 4 SS 01 Tunneling Tool Straw TTS 01 RNS System User Manual System Products Components Accessories amp Tools 99 NeuroPace Lead Accessory Kit Model LA 02 K Item Model Number Lead Cap 2 LC 01 Suture Sleeves 4 SS 01 Stop Gauge SG 01 Tunneling Tool TT 01 Tunneling Tool Tip TTT 01 Tunneling Tool Straw TTS 01 NeuroPace Programmer Kit Model PGM 300 K Item Model Number NeuroPace Programmer PGM 300 Carrying Case PC 01 Used With Wand W 02 NeuroPace Remote Monitor Kit Model DTR 300 K Item Model Number NeuroPace Remote Monitor DTR 300 Telephone Cord Telephone Line Splitter Carrying Case PC 01 Used With Wand W 02 RNS System User Manual System Products Components Accessories amp Tools 100 Craniectomy Template Kit Cranial Prosthesis Kit
12. PATTERN B tabs The simulated detection will be displayed in green on the ECoG as displayed in this example p Display Options gt Simulation Options NAGS Details Timebase Seconds Sensitivity Pe Make Add Edit Waveform IV Wavelom I Device Markers IV Auto Simulate Pirersriwris Mix rx aae eaa I Spectrogram Minor Grid T Detection Features 30 60 IV En amp eECoG M 4x M e EGG Next ECoG Length 90 060 Seconds Cursor Position a 5 5 2 E a E ic SES Bae ur Second Detector Amplitude 4 Amplitude Figure 27 X o N Detection Simulation Note f simulating performance of a 2 channel detection set be sure to select ECoG records that contain signal data for both channels Once the detection settings are found to be appropriate go to the DETECTORS tab and enter a detection set name or select GENERATE NAME Confirm DETECTION is enabled or disabled as desired RNS System User Manual Programming Instructions 70 Recommended Initial Detection Settings Program initial detection settings on the DETECTION tab as follows e Select Default Line Length 75 on Ch 1 amp 3 Click on the name e Set Detection Status to ENABLED Detectors ECoG List Pattern A First Detector Pattern B Second Detector Date Time Thu Apr 01 2010 11 31 29 Pacific Daylight Time GMT 7 Line Length 75 on Ch 1 amp 3 Mon Apr 30 2007 14 12 12 Pacific Daylight Time GMT 7
13. PROGRAMMING INSTRUCTIONS ecccecceeeceeeceeeceeeeeeeeceseee cece enne nnne nn nn nn entr tn tr sn tr nsn nn nn nnns tr ss tns trn tnnt 55 LOGGING ONTO THE NEUROPACE PROGRAMMER tette eter 55 TESTING THE WAND SIGNAL adeat Ede tee er ecc Lo eee b ee HE e adhd en etes 55 INTERROGATING THE RNS NEUROSTIMULATOR iri ennt tnter ctn hn rite tnt bt 55 IMPEDANCE MEASUREMENTS 1 eee ERI Hera te HERR dee dedi dete adhe Ve et ER 56 BATTERY VOLTAGE MEASUREMENTS 3 e ae dit eee eb e E De eher EO ET ne Heo BE ete Ed dde 56 CAPTURING Real time ECOG S iisisti enoii deei e ede te tee ete e d v ei cu tane edu edu rae a o dde 56 OBTAINING NEUROSTIMULATOR ACTIVITY INFORMATION iseseeeeeee ener rne ee nennen 57 REVIEWING ECOG RECORDS RETRIEVED FROM THE RNS NEUROSTIMULATOR eeeees 57 DELIVERING TEST SIMULATION S a che pene en e T eee aea ad ne d ed e Ee odio deas 58 SYNCHRONIZING THE PROGRAMMER WITH THE NEUROPACE PATIENT DATA MANAGEMENT SYSTEM 59 PATIENT INFORMATION AND PHYSICIAN EMERGENCY CONTACT INFORMATION eene ees 60 RNS System User Manual Entering Patient Information into the Programmer sss sisse enne einn nnne 60 Entering Physician Emergency Contact Information eese 60 Programming Information iur eden b e e p b d ned 60 ASSIGNING LEAD LABELS AND CREATING THE MONTAGE 2 cccccceceeeceeeeeeeeceeeceaeeeaeeeeeeecaeeeaeeseeeeeeeeeneesaee
14. SPECIFICATIONS seee tette tte teretes 91 RNS SYSTEM LEAD SPECIFICATIONS sette tette tette ttt 91 RNS SYSTEM LEAD SPECIFICATIONS seettett tette tete tette tette tid 91 IMPLANTABLE RNS SYSTEM COMPONENTS AND ACCESSORIES se ssssessessessssesseteesessessesessnseessesesseseen 92 NEUROPACE PROGRAMMER ss essessessssessessessesseseessessesseeuseecsnceessncetssetstssesitsaetitsiesstsiesstsissessnseessnseeesees 92 ELECTROMAGNETIC EMISSIONS AND IMMUNITY essent nnne rennen renes 93 SYSTEM PRODUCTS COMPONENTS ACCESSORIES AND TOOLS see 98 c Ro c7 l S 101 INDEX qc OP 107 RNS System User Manual Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply AN Caution Do Not Resterilize Hg MR Unsafe Rony Prescription Only WK Pyrogen Free Single Use STERILEEO Sterilized Using Ethylene Oxide y Temperature Limits RNS System User Manual RNS System User Manual Introduction 5 INTRODUCTION CONTACTING NEUROPACE All questions or concerns regarding the NeuroPace RNS System should be forwarded to NeuroPace Inc 455 N Bernardo Ave Mountain View CA 94043 Customer Support 1 866 726 3876 Toll Free in the United States Fax 650 237 2855 Website www NeuroPace com ABOUT THIS MANUAL This manual is intended to
15. an electrode to each CHANNEL CH1 through CH4 by selecting either a non inverting or inverting input Each electrode can be assigned to one or two channels Use a positive input for electrodes assigned to 2 channels 3 Assign a GAIN for each channel by selecting a high medium high medium low or low value The ECoG signal amplification may be assessed following programming by viewing the real time ECoGs Note Using a negative input for electrodes assigned to 2 channels may result in ECoG artifacts Recommended Initial Montage settings Program the initial ECoG sensing montage on the MONTAGE tab as follows e CH1 Lead 1 Electrode 1 Electrode 2 e CH2 Lead 1 Electrode 3 Electrode 4 e CH3 Lead 2 Electrode 1 Electrode 2 e CH4 Lead 2 Electrode 3 Electrode 4 e All GAIN settings on HIGH Patient Product S Test Stimulation Montage Detection ECoG Storage Responsive Therapy Montage Electrode CH 1 CH 4 10 mm spacing 30 cm length 0 0 NP 4 Electrode 7 9 mm2 Depth Lead RHip2 I 10 mm spacing 30 cm length RHip3 101789 RHip4 Gain High High High High Note Each electrode can be assigned to 1 or 2 channels Use a positive input for electrodes assigned to 2 channels Figure 22 Montage tab RNS System User Manual Programming Instructions 64 Programming the Newly selected Settings Programming the RNS Neurost
16. due to outside forces severe brain tissue damage could result from exposure to the battery chemicals WARNING ELECTROMAGNETIC INTERFERENCE EMI Electromagnetic interference is a field of energy generated by equipment found in the home work medical or public environments that is strong enough to interfere with neurostimulator function Sources of strong electromagnetic interference can result in the following effects e Serious patient injury or death It is possible for the interference sources to couple enough energy into a Neurostimulator system to damage brain tissue e System damage resulting in a loss or change in symptom control and requiring reoperation e Operational changes to the neurostimulator causing stimulation to turn on or off or resetting or reprogramming the Neurostimulator resulting in a return of symptoms e Unexpected changes in stimulation causing a momentary increase in stimulation which may be felt by the patient Patients should exercise caution in avoidance of devices which generate a strong electric or magnetic field Refer to Electromagnetic Emissions and Immunity for more information WARNING RADIO FREQUENCY IDENTIFICATION RFID INTERFERENCE Sources of RFID can result in signals that appear as ECoG activity to the Neurostimulator Signals that appear as ECoG activity could also result in delivering the programmed stimulation to the patient per the device detection programming The physician shoul
17. of the therapies The NeuroPace Programmer may also be used on its own to review previously retrieved Neurostimulator activity information perform detection analysis and to communicate with the NeuroPace Patient Data Management System PDMS via connection over the Internet RNS System User Manual Responsive Neurostimulator System 25 Figure 4 The NeuroPace Programmer and Wand are used to communicate with the RNS Neurostimulator TELEMETRY WAND Wand Model W 02 The Wand is placed over the implanted RNS Neurostimulator to facilitate communication with the Programmer It is connected to the Laptop component of the Programmer via a USB cable NEUROPACE PATIENT DATA MANAGEMENT SYSTEM NeuroPace Patient Data Management System Model 4330 The Patient Data Management System PDMS maintains patient and product data obtained from the NeuroPace Programmer and Remote Monitor Authorized users may access the PDMS via the Internet using a personal computer An electronic signature in the form of a user name and password are required for user authentication For additional information on using the PDMS refer to the Patient Data Management System User Manual RNS System User Manual Responsive Neurostimulator System 26 STERILIZATION STORAGE AND HANDLING Handling Products The products of the RNS System are to be handled with extreme care e Handle the Lead with care e Bending kinking and stretching of t
18. processors e Electric blankets and heating pads e Personal computers electric typewriters copiers and fax machines e Televisions AM FM radios stereos personal music players e Vacuum cleaners and electric brooms For additional information about devices that generate electromagnetic interference contact NeuroPace If a patient suspects EMI is disrupting the operations of their Neurostimulator advise the patient to move away from the source of the EMI Guidance and Manufacturer s Declaration Medical electrical equipment needs special precautions regarding EMC and needs to be installed and put into service according to EMC information provided This declaration applies for the following devices e RNS Neurostimulator model RNS 300M e Programmer model PGM 300 e Wand model W 01 e Remote Monitor model DTR 300 The devices comply with IEC 601 1 2 ISO 14708 3 and FCC 47 CFR Parts 2 and 15 e Portable and mobile RF communications equipment can affect the devices e This equipment system may cause radio interference or may disrupt the operation of nearby equipment The devices may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements It may be necessary to RNS System User Manual Specifications 94 take mitigation measures such as re orienting or relocating the devices or shielding their location e The NeuroPace Programmer should not be used adjace
19. s and dispose of the old Connector Cover Place a Lead Cap over the proximal contacts of the abandoned Lead s The Lead Cap s should be secured with a suture Flush the Neurostimulator connector area if necessary to remove debris and dry area before attaching the Connector Cover Hold the Connector Cover with the windows visible Place the Lead proximal end into each port in the Connector Cover until the Leads stop Confirm that the Lead marker band is flush with the edge of the Connector Cover If there is a gap between the band and the edge of the Connector Cover seal gently push the Lead into the Connector Cover port again until the Lead stops Confirm that the Lead contacts are fully visible in each window of the Connector Cover Figure 14 Place the Connector Cover on the Neurostimulator and then loosely attach it to the Neurostimulator using the Torque Driver Ensure that the Leads remain completely inserted in the Connector Cover Note DO NOT use any tools other than the Torque Driver provided to secure the Connector Cover in place Fully attach the Connector Cover to the Neurostimulator by tightening the screw until the Torque Driver clicks Place the upper Lead Strain Relief over the proximal ends of the Leads extending from the Connector Cover and attach it to the post If using only one Lead be sure to place a Connector Plug in the vacant Connector Cover port Precaution Connector Plug A vacant port in th
20. secure web site that provides a means to review information that has been up loaded by the Programmer Patterns Patterns Pattern A and Pattern B use a collection of detection tools to classify electrographic activity Post episode monitoring interval Responsive therapies will be DISABLED for this period of time after detecting the end of an episode Post episode therapy Therapy that is delivered following an episode containing responsive therapy Post episode therapy will only be delivered if the setting is programmed as ENABLED Post trigger ECoG storage Neurostimulator setting which indicates the duration of ECoG data that will be stored in the Neurostimulator after an ECoG triggering event Pre trigger ECoG storage Neurostimulator setting which indicates the duration of ECoG data that will be stored in the Neurostimulator prior to an ECoG triggering event Programmer The Programmer is a Laptop personal computer that runs software developed by NeuroPace to communicate with the Neurostimulator to download selected settings into the Neurostimulator and to upload information from the Neurostimulator The Programmer communicates with the Neurostimulator via the Wand The Programmer also communicates with the PDMS via an internet connection Programming Using the Programmer to program settings into the Neurostimulator Programming pause time The time during which the Programmer is sending new settings to the Neurostimulator This pa
21. signal is not sufficient or still contains noise or artifacts measure the impedances If the impedances are out of range follow the instructions in the Abnormal Impedance Measurements section of this manual RNS System User Manual Troubleshooting 87 13 If impedance measurements are normal but the problem remains try using a different Programmer if available 14 If the problem persists replace the Neurostimulator Refer to the Replacing Explanting the RNS System section in this manual Troubleshooting During a Routine Follow up 1 2 Reposition the Wand over the RNS Neurostimulator and interrogate again If the signal is not sufficient follow the Poor or No Communication Between the RNS Neurostimulator and the Programmer instructions in this section If the signal is not sufficient measure the impedances If the impedances are out of range follow the instructions in the Abnormal Lead Impedance section of this manual Poor or No Communication Between the RNS Neurostimulator and the Programmer 1 o ouo Confirm that the Wand cable is inserted securely into the USB port at the rear of the Programmer Confirm that the concave side of the Wand faces the Neurostimulator and that the Wand is within approximately 1 inch of the Neurostimulator Test the Wand signal and lack of noise quality by selecting the TEST THE WAND button on the Main Menu screen Disconnect the AC adapter from the Programmer a
22. the cause of the reset and contact NeuroPace Responsive therapy Electrical stimulation output to cortical tissue by the Neurostimulator in response to Pattern A or Pattern B detection RNS Neurostimulator An implantable battery powered microprocessor controlled device that can amplify and analyze the patient s electrocorticographic activity detect activity from intracranial electrodes and deliver a short train of current pulses to the brain to attempt to interrupt the detected activity Saturation event detector Saturation occurs when an input signal exceeds the dynamic range of a particular channel The Neurostimulator incorporates a saturation detector to reduce occurrences of detecting saturation as a neurological event Scheduled ECOG storage A selectable Neurostimulator function that causes the Neurostimulator to store an ECoG at the desired time s of day Simulate performance Simulation uses the Programmer to test a proposed set of detection settings with retrieved ECoGs The simulation will generate markers simulating how the Neurostimulator may detect if those settings are programmed into the Neurostimulator Simulated markers During detection analysis when detection simulation is performed simulated markers are generated to indicate the type of electrographic activity that would be detected using the proposed detection settings Stereotactic frame A medical device that is attached to the patient s head and provides
23. time ECoGs to verify that the signal is sufficient and without noise or artifacts e Repeat impedance measurements 7 Ifthe impedance remains abnormal replace the Neurostimulator Refer to the Replacing Explanting the RNS System section in this manual RNS System User Manual Troubleshooting 86 Troubleshooting During a Routine Follow up 1 2 Repeat Lead impedance measurements to verify abnormal Lead impedance Take an image X ray or CT scan of the implanted Lead s and Connector Cover to discern the integrity of the Lead e Lead Damage If the Lead is damaged or fractured it is recommended to abandon and replace the Lead Refer to the Changing the Leads that are connected to the Neurostimulator section of this manual e Poor Connection If the Lead is not completely installed in the Connector Cover it is recommended to surgically revise the connection between the Connector Cover and Lead Refer to the Changing the Leads that are connected to the Neurostimulator section of this manual Note Itis normal for Lead impedance measurements to fluctuate following the implant procedure due to the acute injury and healing processes of the brain tissue Note Lead damage may not be immediately apparent from the real time ECoGs Using the NoisE ECoG storage trigger may be helpful in future troubleshooting techniques Noise Artifacts Poor Signal Displayed or No Signal Displayed in Real time ECoG Troubleshooting Dur
24. to creating the craniectomy The location and orientation of the incision line relative to the RNS Neurostimulator device should be planned to facilitate future Neurostimulator replacement Consider the following e The portion of the incision that will need to be re opened to replace the Neurostimulator should not traverse the Lead s e The incision should be relatively close to the Ferrule Clamp and Connector Cover for ease of access e The incision should allow for good exposure of the Neurostimulator and the Connector Cover area if necessary Figure 10 Recommended placement of the craniectomy in the skull RNS System User Manual Surgical Procedures 42 1 2 3 Make a scalp incision at the desired Neurostimulator implant location Trace the Craniectomy Template on the skull at the implant location Using a standard perforator perform a craniectomy around the outside edge of the template tracing Elevate the perforated portion of the skull to expose the dura WARNING INTRACRANIAL HEMORRHAGE Intracranial hemorrhage may occur when implanting the RNS System Placing the Leads Ferrule and or Neurostimulator in an area where excess pressure may occur to the underlying blood vessels may cause intracranial hemorrhage Patients with underlying risk factors for intracranial hemorrhage such as patients with previous head trauma or anticoagulant use should be taken into specific consideration RNS Neurostimulator I
25. 1 0 uC sq cm P Cherge Density 1 0 uC sq cm RHip2 RHip3 RHip4 Can Advanced Settings Therapy Testing Copy To Therapy 2 Burst Status Txl Tx2 Tx3 Tx4 Tx5 Burst Enabled Burst Enabled Enabled Enabled Enabled Responsive Therapy Enabled Figure 37 Therapy 1 tab RNS System User Manual Programming Instructions 80 Recommended Modifications to Responsive Therapy Settings Based on the clinical response the physician may choose to modify stimulation If the physician chooses to modify stimulation it is recommended that the current amplitude be increased in 0 5 mA increments It is recommended that stimulation settings be tested using the Test Stimulation function to ensure that it is well tolerated by the patient and there are no undesired changes in the ECoG such as afterdischarges e Review device data such as lead impedance battery voltage number of detection and stimulations and stored ECoGs e Adjust stimulation settings if the patient reports an acute worsening or increase in clinical seizures that is not typical e Consider making minor adjustments if the patient reports only a mild or no improvement in clinical seizures e Allow sufficient time between stimulation adjustments to assess the patient s clinical seizure response In the RNS System Pivotal study very few subjects used any of the additional responsive stimulation ther
26. 42 lt NEUROPACE RNS System User Manual X Only 2013 NeuroPace Inc Rev Date 11 2013 DN 1014633 Rev 4 This Manual supports e RNS Neurostimulator Model RNS 300M with firmware version 7 0 e NeuroPace Cortical Strip Lead Models CL 315 10 CL 325 10 CL 335 10 e NeuroPace Depth Lead Models DL 330 3 5 DL 330 10 DL 344 3 5 DL 344 10 e NeuroPace Programmer Model PGM 300 with software version 1 6 FCC Information The following is communications regulation information on the Model RNS 300M Neurostimulator and Model W 02 Wand Neurostimulator FCC ID WBWRF300 Wand FCC ID WBW902 This device complies with Part 15 of the FCC Rules Operation is subject to the following two conditions 1 This device may not cause harmful interference and 2 this device must accept any interference received including interference that may cause undesired operation IMPORTANT Changes or modifications to this product not expressly approved by NeuroPace Inc could void the FCC Certification and negate your authority to operate them This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment This transmitter must not be co located or operating in conjunction with any other antenna or transmitter TABLE OF CONTENTS INTRODUCTION Peer 5 CONTACTING NEUROPACE 2i Ie o ret e ae Hebr dede od e Meenas 5 ABOUT THIS MANUAL rire tete eti cep P ERE elt OA I porn TEE OUR EU e adeste tita ee
27. 8 5 mm including Lead Strain Relief WEIGHT 16g 18 g including Connector Cover amp Lead Strain Relief VOLUME 11 cc MATERIAL Titanium OPERATING TEMPERATURE 14 to 42 C NUMBER OF OUTPUT CHANNELS Up to 8 electrodes 4 per Lead and the Neuro stimulator can are selectable for use in stimulation CURRENT VOLTAGE REGULATED Current regulated MAX OuTPUT CURRENT AT 500 OHMS 11 5 mA 10 800 OHMS 9 6 mA x 1096 1200 OHMS 6 0 mA x 10 MAX OUTPUT VOLTAGE AT 500 OHMS 6 0 V 10 800 OHMS 9 6V 10 1200 OHMS 12 0 V 10 FREQUENCY 1 to 333 Hz 3 3 to 1000 msec p p Interval BURST DURATION 10 msec to 5 seconds CHARGE IMBALANCE lt 10 uC sec at 50 Hz 5 mA and 120 usec phase MAXIMUM CHARGE DENSITY 25 uC cm limited by programmable selections BATTERY LIFE 2 to 3 5 years see RNS System Longevity section for details INTERVAL BETWEEN ERI AND EOS 3 months VOLTAGE AT ERI MINIMUM AVERAGE 2 75 V VOLTAGE AT EOS MINIMUM AVERAGE 2 70 V RNS System User Manual Specifications 91 RNS SYSTEM WIRELESS SPECIFICATIONS RNS System Wireless Specifications RNS SYSTEM LEAD SPECIFICATIONS RNS SYSTEM LEAD SPECIFICATIONS GonalStipLeads Depthleads LENGTHS 15 cm 25 cm and 35 cm 30 cm and 44 cm LEAD BoDY Isodiametric Isodiametric DISTAL END 1 x 4 array 1 x 4 array NUMBER OF ELECTRODES 4 ELECTRODE SPACING AVAILABLE 3 5 mm and 10 mm 15 Ohms 10 for 15 cm Lead CONDUCTOR RESISTAN
28. B Detection Off po Saturation on 0 Noise Off mai Scheduled ECoG Storage Start Times Scheduled Storage on 0 03 00 15 00 Unused Unused Reservations Remaining 2 Max ECoG capacity as configured 4 Figure 26 ECoG Storage tab Programming the Newly Selected ECoGs Storage Settings 1 Select the PROGRAM SETTINGS tab 2 Select REVIEW CHANGES to view changes prior to programming 3 Select the PROGRAM button RNS System User Manual Programming Instructions 69 SETTING UP DETECTION Detection settings are used by the RNS Neurostimulator to recognize epileptiform activity as defined by the physician Enabling Disabling or Changing the Detection Settings 1 2 3 Go to the CONFIGURE SETTINGS tab Select the DETECTION tab Select a detection setting file which may be any of the following e A default file for a one or a two Lead configuration e A file previously created developed and saved during a Configure Detection session e A file retrieved from the Neurostimulator during interrogation and generated using the SAVE button e A file downloaded from the PDMS and accepted If desired modify the detection set by adjusting specific detection parameters Simulate the performance of the newly selected detection settings Detection simulation is performed on the ECoGs available on the Programmer Simulation can be accomplished by selecting Auto Simulate from the ECOG LIST PATTERN A OR
29. Before programming Responsive Therapy at least one detector must be defined in a detection set If detection pattern specific therapy is selected at least one detector must be defined for each pattern Detection must be enabled before Responsive Therapy can be enabled Enabling Disabling or Changing Responsive Therapy 1 2 3 5 6 Go to the Configure Settings tab Select the RESPONSIVE THERAPY tab Select PosT EPISODE INTERVAL to determine the time the RNS Neurostimulator waits after detecting the end of activity before recognizing a new episode If a new episode begins before the end of the post episode interval no bursts are delivered during the new episode Select THERAPY Limit PER DAY to set the number of episodes that may be treated by the Neurostimulator per day The therapy limit counter is restarted whenever the Neurostimulator is re programmed Select a channel configured for PULSE INTERVAL ADAPTATION if desired Select the channel for SYNCHRONIZATION if desired To set up a therapy sequence determine the number of therapies desired for delivery in response to an episode Select each therapy and configure each burst which is a collection of one to many biphasic pulses 1 Select the stimulation pathway by choosing at least one electrode or the Neurostimulator can as the anode and at least one electrode or the Neurostimulator can as the cathode for the stimulation Select the level of CURRENT that wil
30. CE 25 Ohms 10 for 25 cm Lead 35 Ohms 10 for 35 cm Lead LEAD BoDY MATERIAL Silicone Silicone 30 Ohms 10 for 30 cm Lead 44 Ohms 10 for 44 cm Lead ELECTRODE MATERIAL Platinum lridium Platinum lridium CoiL MATERIAL Platinum lridium Platinum lridium STYLET MATERIAL Tungsten Parylene coated Tungsten Parylene coated STYLET RETAINER Nvlon Nvlon MATERIAL y y RNS System User Manual Specifications 92 IMPLANTABLE RNS SYSTEM COMPONENTS AND ACCESSORIES Implantable Component and Accessory Materials Component or Accessory Material CONNECTOR COVER Polyaryletheretherketone Titanium CONNECTOR PLUG Silicone FERRULE Titanium FERRULE CLAMP Polyaryletheretherketone Titanium LEAD CAP Silicone LEAD STRAIN RELIEF Silicone SUTURE SLEEVE Silicone NEUROPACE PROGRAMMER Programmer and Components Materials Weights and Operating Temperatures Programmer Wand DIMENSIONS 3 3 x 35 x 24 cm typical 18 cm x 9 cm MATERIAL Commercial Materials ABS copolymer WEIGHT 2 kg typical 240 g 0 C to 35 C 0 C to 35 C RNS System User Manual Specifications 93 ELECTROMAGNETIC EMISSIONS AND IMMUNITY Electromagnetic interference EMI is a field of energy generated by equipment found in the home work medical or public environments that is strong enough to interfere with Neurostimulator function The RNS System is designed to be immune from common sources
31. Contact NeuroPace for further assistance Impedance Measurement was Rejected Test Request was Rejected Message Impedance measurement was rejected by the Neurostimulator Test request was rejected by the Neurostimulator Issue The Neurostimulator cannot perform an impedance measurement or a Test Stimulation Therapy Testing Possible Cause e The Neurostimulator may be delivering therapy Impedance measurement or Test Stimulation cannot be performed during responsive therapy e The Neurostimulator may be detecting an episode Impedance measurement or Test Stimulation cannot be performed while an episode is being detected Actions to be Taken 1 Temporarily disable detection in order to proceed with the Test Stimulation or impedance measurement or 2 Wait until the Neurostimulator is no longer detecting an episode RNS Neurostimulator Reset DC Leak Detected Message Neurostimulator SN xxxxxx has reset Reset Reason DC leak detected PC 49159 Data 0 Copy the above information exactly for technical support The Neurostimulator will not detect or deliver therapy until it has been programmed Select Continue and additional information will be gathered on the reset Issue The Neurostimulator has reset It cannot detect or deliver therapy until it is programmed Possible Cause A direct current DC leak was detected when electrocautery was performed during surgery RNS System User Manual Troubleshooting
32. Each time the Magnet is placed the time of placement is stored in the Neurostimulator e Test Stimulation cannot be delivered while the Magnet is in place e Impedance measurements cannot be made while the Magnet is in place RNS System User Manual Patient Follow Up Activities 83 PATIENT FOLLOW UP ACTIVITIES The following activities are recommended at a follow up visit 1 Interrogate the RNS Neurostimulator Review information under SUMMARY tab Select REVIEW DATA tab Note Refer to the NeuroPace Patient Data Management System for historic Neurostimulator information Review stored ECoGs Test system integrity by obtaining electrode impedance measurements If not already displayed measure the battery voltage Note Electrode impedance and battery voltage are automatically measured and displayed during interrogation If these two values were not measured e g because therapy was being delivered measure them manually using the applicable buttons on the screen View real time ECoGs Deliver Test Stimulation s to test previous or new therapy tolerance if necessary Perform detection simulation if changes to the detection parameters are desired Program new settings into the Neurostimulator if necessary Precaution Afterdischarge Activity If evidence of afterdischarge activity resulting from stimulation is seen either on stored ECoGs or during Test Stimulation delivery stimulation parameters should be ad
33. Modifications to Responsive Therapy Settings sss 80 Programming the Newly Selected Settings essen 80 REVIEWING REEORITS 2 4 tede ardere erect eee A edel a e ede e e een eed er ce qe e tens lett 81 Lcl z mec C 82 PATIENT FOLEOW UP ACTIVITIES icit rite et tet funded rre baa aei ene e Doe Luo ces 83 TROUBLESHOOTING 4 Int eee tiere chun tec Depart aec e eed cit e bcr tn advance deh ed ecl ae aea Eau 84 DAMAGED PRODUCTS x ite thesis the a E aa a Head erbe ant aa hee opo qe harte tenent Sees anderes the ds 84 GENERAL TROUBLESHOOTING ACTIVITIES 2 2 2 epeto Ie tod tradenda oe etu ia Pet e une pA ded estne duree thai a 84 Abnormal Lead Impedance greater than 3500 Ohms or less than 250 Ohms sssssl 84 Noise Artifacts Poor Signal Displayed or No Signal Displayed in Real time ECOG 86 Poor or No Communication Between the RNS Neurostimulator and the Programmer 87 Programmer Turns OFF or Freezes onipin essentia their en rns a enter renes anna 87 Low Battery Measurement sessi essei n eese AA AAAA AN NEA A AREA EN SR ia 88 Impedance Measurement was Rejected Test Request was Hejected sssssssss 88 RNS Neurostimulator Reset DC Leak Detected sssse tette 88 SPECIFICATIONS a E 90 RNS NEUROSTIMULATOR SPECIFICATIONS ee tette teretes 90 RNS SYSTEM WIRELESS
34. NS Neurostimulator port to which the Lead is connected 1 Repeat the impedance measurements 2 If the impedance remains abnormal note the electrode label associated with the abnormal impedance 3 Reconnect Leads in the same Neurostimulator port e Disconnect and reconnect the Leads to the Connector Cover and Neurostimulator according to the instructions in the Noise Artifacts Poor Signal Displayed or No Signal Displayed in Real time ECoG section of this manual e View the real time ECoGs to verify that the signal is sufficient and without noise or artifacts e Repeat impedance measurements 4 Ifthe impedance remains abnormal note the electrode label associated with the abnormal impedance 5 Place Leads in the opposite Neurostimulator port e Disconnect Leads place Leads in the opposite Connector Cover ports and reconnect the Connector Cover and Neurostimulator according to the instructions in the Noise Artifacts Poor Signal Displayed or No Signal Displayed in Real time ECoG section of this manual RNS System User Manual Troubleshooting 85 e Program the new Lead information and montage and use the same electrode labels for the new Lead configuration e View the real time ECoGs to verify that the signal is sufficient and without noise or artifacts e Repeat impedance measurements Note Ifthe abnormal impedance is associated with the same electrode label then the problem may be with the Lead Depth Le
35. PREGNANT WOMEN The safety and effectiveness of the RNS System has not been studied in pregnant women WARNING RNS SvsTEM FAILURE As with any electronic device the RNS System may malfunction not work Potential causes include battery malfunctions an electrical short open circuits Lead fractures Lead insulation failures or damage as a result of head trauma These malfunctions are unpredictable and may result in too little stimulation or no stimulation A Lead failure may result in the lead needing to be removed or repositioned which would require surgery A malfunctioning Neurostimulator may need to be replaced which would require surgery Although the Neurostimulator is designed to turn off if overstimulation or excess current occurs there is a possibility that product failure could result in brain tissue damage RNS System User Manual Responsive Neurostimulator System 12 WARNING NEED FOR ANALOG PHONE LINE The patient must have access to an analog phone line in order to transmit data at least once a week to the PDMS database so that the physician can monitor device function including battery life and assess whether programming changes are necessary WARNING PATIENT DATA COLLECTION The patient must be willing to collect data daily from their Neurostimulator and send the data via an analog phone line to the PDMS database at least once a week WARNING CASE DAMAGE If the Neurostimulator case is ruptured or pierced
36. PROGRAM button REVIEWING REPORTS Reports containing the RNS Neurostimulator programmed settings event history since last interrogation and ECoGs may be displayed for each Programmer session Reports are also stored on the Programmer for battery and impedance measurements and saved Detection Sets Reviewing Reports and ECoGs 1 Goto the Programmer MAIN MENU screen 2 Select the REVIEW REPORTS button 3 Choose patient serial number 4 Choose the report type to review Histograms are available when viewing interrogation reports To view long term up to 28 days of diagnostic information 1 Select the HISTOGRAMS tab 2 Select Month by Day or Day by Hour Note Historic Neurostimulator information stored ECoGs and real time measurements are available through the PDMS RNS System User Manual Magnet 82 MAGNET The Magnet suppresses RNS System therapy as long as the Magnet is held in position over the Neurostimulator Placing or swiping the Magnet over the Neurostimulator stores the time of placement in the Neurostimulator and can also trigger ECoG storage if the Neurostimulator is programmed to do so Inform the patient about the proper use of the Magnet Information about the Magnet e While the Magnet is placed within one inch of the Neurostimulator therapies are not delivered Therapies are re enabled upon removal of the Magnet e Detection and ECoG storage continue while the Magnet is in place e
37. RF communications equipment and the RNS System for equipment that are not life supporting Rated Separation distance according to frequency of transmitter maximum m output power of transmitter 150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2 5 GHz W dz 1 174P d 1 17VP d 2 334P 0 01 0 12 0 12 0 23 0 1 0 37 0 37 0 74 1 1 17 1 17 2 33 10 3 70 3 70 7 39 100 11 70 11 70 23 3 a At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people For transmitter rated at a maximum output power not listed above the recommended separation distance of d in meters m can be estimated using the equation applicable to the frequency of the transmitter where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer RNS System User Manual System Products Components Accessories amp Tools 98 SYSTEM PRODUCTS COMPONENTS ACCESSORIES AND TOOLS Note Manuals and other literature are not listed below Model RNS 300M K NeuroPace RNS Neurostimulator Kit Item Model Number NeuroPace RNS Neurostimulator RNS 300M Connector Cover CC 01 Craniectomy Template CT 01 Ferrule F 01 Ferrule Clamp FC 01 Lead Strain Relief LSR 01 Torque Driver TD 01
38. Remove the Stop Gauge and frame components from the Lead 2 While holding the Lead in place at the skull disengage the stylet from the Lead by pinching the stylet retainer and gently pulling the stylet away from the Lead body Note Do not reinsert the stylet into the Lead after it has been removed 3 Gently pull the insertion cannula up over the Lead Figure 9 while stabilizing the lead at the burr hole to avoid lead migration RNS System User Manual Surgical Procedures 39 Stylet Retainer Insertion Cannula fg Lead Stylet Lead Figure 9 Removal of the insertion cannula stylet and stylet retainer from the Lead 4 Leave approximately 10 15 mm of the Lead inside the burr hole allowing slack in the Lead before securing the Lead to the skull 5 If using a burr hole cap cover not provided follow the manufacturer s Instructions for Use for securing the Lead to the burr hole 6 If implanting more than one Lead mark the Lead near the proximal Lead contacts with a marker such as non absorbable sutures in order to identify the Lead Precaution Suture Sleeves Suture Sleeves are provided for use if sutures are used to stabilize the Lead Suturing directly on the Lead may cause Lead body damage and malfunction RNS System User Manual Surgical Procedures 40 T Place Lead Caps provided on the proximal end of unconnected Leads and place the excess Lead in a sub galeal pocket near the bur
39. a three dimensional frame of reference for accurate implantation of depth Leads Stereotactic surgery Surgery in which a system of three dimensional coordinates is used to locate the site to be operated on Stim pathway Collective term describing the anodes and cathodes selected for a burst Stop Gauge The Stop Gauge is placed on a Depth Lead prior to implantation to indicate the appropriate depth of its insertion Storage start time Scheduled ECoG storage setting controlling the time s at which ECoG storage will be triggered Stylet Support wire contained in both the Cortical Strip And Depth Leads The stylet is removed after proper Lead placement has been achieved Summary Programmer interactive display of a record of the Neurostimulator activity occurring since the last interrogation Suture Sleeve The Suture Sleeve is intended to protect the Lead body at the point at which the Lead is sutured to subcutaneous tissue to immobilize it and prevent its dislodgement while chronically implanted Synch channel The Neurostimulator will monitor this channel for ECoG signal peaks to calculate synchronous delivery timing One channel will be used for all bursts selected to have synchronous pulse delivery Synchronize data The action of transferring data via the internet to the PDMS Synchronous pulse Delivering the first pulse in a burst or after a first pulse delay Synchronous from a peak in an ECoG signal Technica
40. ad Impedance 3500 Ohms e The Depth Lead may be damaged and should be replaced Refer to the Changing the Leads that are connected to the Neurostimulator section in this manual Depth Lead Impedance 250 Ohms e The Depth Lead may be damaged and should be replaced Refer to the Changing the Leads that are connected to the Neurostimulator section in this manual Cortical Strip Lead Impedance 3500 Ohms e The high impedance may be due to air e irrigate the area around the Cortical Strip Lead and examine the geometry e Repeat impedance measurements e _ If the impedance remains abnormal the Cortical Strip Lead may be damaged and should be replaced Refer to the Changing the Leads that are connected to the Neurostimulator section in this manual Cortical Strip Lead Impedance 250 Ohms e The Cortical Strip Lead may be damaged and should be replaced Refer to the Changing the Leads that are connected to the Neurostimulator section in this manual Note Ifthe abnormal impedance is not associated with the same electrode label the problem may be with the Neurostimulator or Connector Cover 6 Replace the Connector Cover e Disconnect the Leads from the Connector Cover and reconnect the Leads to a new Connector Cover Connect to the Neurostimulator and troubleshoot according to the instructions in the Noise Artifacts Poor Signal Displayed or No Signal Displayed in Real time ECoG section of this manual e View the real
41. adiation oncologist should consult with the physician prescribing the RNS System RNS System User Manual Responsive Neurostimulator System 14 WARNING ELECTROLYSIS The effects of electrolysis on the RNS System have not been studied Electrolysis on the head or neck should be avoided WARNING COMPUTERIZED TOMOGRAPHY CT SCANS For CT procedures on a patient with an implanted RNS Neurostimulator the operator should e Ask the patient to have the Neurostimulator temporarily shut off with a Programmer while the scan is performed if possible e Minimize x ray exposure to the implanted electronic medical device by e Using the lowest possible x ray tube current consistent with obtaining the required image quality e Making sure that the x ray beam does not dwell over the device for more than a few seconds Important note For CT procedures that require scanning over the medical device continuously for more than a few seconds as with CT perfusion or interventional exams attending staff should be ready to take emergency measures to treat adverse reactions if they occur After CT scanning the operator should e Ask the patient to have the Neurostimulator turned back on with a Programmer if it had been turned off prior to scanning e Advise the patient to contact their healthcare provider as soon as possible if they have questions or suspect their device is not functioning properly after any medical procedure RNS System User M
42. adjusting the amplifier gain settings and storing real time ECoG records Stored real time ECoG records are available during detection stimulation REVIEW REPORTS and ARCHIVED DATA Programmer sessions The real time ECoG is classified as user saved Note Itis important to remember that the Lead labels and montage must be programmed before real time ECoGs may be viewed RNS System User Manual Programming Instructions 57 Viewing Real time ECoGs 1 Keep the Wand in place over the Neurostimulator 2 Goto REVIEW DATA tab 3 Select the REAL TIME ECoGs tab Storing a Real time ECoG 1 Select the STOP button to stop the ECoG from scrolling 2 Select the STORE button to save the ECoG record Note The maximum length for a real time ECoG is four minutes If the real time ECoG is allowed to scroll for more than four minutes only the last four minutes are stored Note Real time ECoGs are stored on the Programmer not in the Neurostimulator memory and are uploaded to PDMS when the Programmer is synchronized Note Real time ECoGs may also be viewed and saved from the TEST STIMULATION tab Precaution Real time ECoG artifact The start and or stop of a real time ECoG may produce an electrographic artifact If responsive therapy is enabled with a sensitive detection set detection of the electrographic artifact may occur resulting in therapy delivery OBTAINING NEUROSTIMULATOR ACTIVITY INFORMATION The summary page displayed
43. after interrogation contains a record of RNS Neurostimulator activity It contains the number and details of the events detected and responsive therapies delivered since the last Neurostimulator interrogation or programming The diagnostic summary is cleared each time the Neurostimulator is interrogated or programmed Note Recently retrieved Neurostimulator information is stored in the Programmer A full history is located on the PDMS Viewing a Detailed Summary of Neurostimulator Activity 1 Go to REVIEW DATA tab 2 The Activity Loc page is displayed To view a list of event types dates and times select DETAILED VIEW button Graphically Viewing Long Term Up To 28 Days of Neurostimulator Activity 1 Goto HISTOGRAMS tab 2 Select Month by Day or Day by Hour REVIEWING ECOG RECORDS RETRIEVED FROM THE RNS NEUROSTIMULATOR Stored ECoGs reside in the RNS Neurostimulator memory until they are retrieved by the Programmer or overwritten by subsequent ECoGs Retrieving ECoGs from the Neurostimulator occurs each time the Neurostimulator is interrogated The ECoGs are then cleared from the Neurostimulator and archived on the Programmer for review RNS System User Manual Programming Instructions 58 Each ECoG stored is listed with the reason for storage trigger and detected events are displayed over the captured ECoG signal It is recommended that stored ECoGs be reviewed to assess the electrographic response to Neur
44. age 30 56 64 65 Elective Replacement Indication ERI 28 90 103 Electroconvulsive Therapy ECT Contraindication 9 Electrolysis 14 ElectroMagnetic Interference EMI 12 Emergency Contact Information 60 End of Service EOS 28 90 103 Erosion 11 Error Messages 84 Explant of product 26 Explanting the RNS System 49 F FCC Information ii Ferrule 23 103 Ferrule Clamp 23 103 Index 108 Fixed pulse interval 103 G Glossary 101 H Handling 26 Hemorrhage See Intracranial hemorrhage Impedance measurement 33 56 88 103 Implant procedure See Surgical Procedures Incineration of product 26 Indications 9 Infection 10 33 Initial Programming 30 31 62 63 65 70 77 Initial Settings 30 31 62 63 65 70 77 Interaction with Implanted Cardiac Devices 13 Interference 18 55 86 87 93 104 Interrogation 55 103 Intracranial Hemorrhage 11 L Lead cap 103 Lead Cap 24 Lead damage 86 Lead Migration 11 Lead Strain Relief 23 103 Line Length Detector 70 Lithotripsy 13 Localization Seizure Focus 29 M Magnet 23 82 103 Magnetic Resonance Imaging MRI Contraindication 9 MR Unsafe 9 Modifying Settings 32 67 70 80 Montage 33 60 63 104 N Need For Analog Phone Line 12 Neurostimulator 105 Assigning Lead Labels 60 62 Battery 27 Connecting to the leads 45 Delivering Test Stimulation 58 Description 22 Detection Settings 30 32 69 70 Eme
45. agnetic environment guidance Electrostatic discharge ESD IEC 61000 4 2 t 6 kV contact t 8 kV air t 6 kV contact t 8 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 3096 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 1 kV for input output lines 2 kV for power supply lines 1 kV for input output lines Mains power quality should be that of a typical commercial or hospital environment Surge IEC 61000 4 5 1 kV line s to line s 2 kV line s to earth 1 kV line s to line s 2 kV line s to earth Mains power quality should be that of a typical commercial or hospital environment Voltage dips short interruptions and voltage variations on power supply input lines IEC 61000 4 11 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles gt 5 U gt 95 dip in U for5s 5 U gt 95 dip in U for 0 5 cycle 40 U 60 dip in U for 5 cycles 70 U 30 dip in U for 25 cycles gt 5 U gt 95 dip in U for5s Mains power quality should be that of a typical commercial or hospital environment If the user of the RNS System requires continued operation during power mains interruptions it is recommended that th
46. ake sure the proximal Lead ends are appropriately marked so the leads can be connected to correct ports of the new Neurostimulator Dispose of the old Connector Cover Precaution Lead Damage Bending kinking and stretching of the Lead may cause Lead damage Handle the Lead with care Using the Torque Driver partially loosen the screw in the Ferrule Clamp and swivel the clamp 90 degrees away from the Neurostimulator to facilitate removal of the Neurostimulator Remove the Neurostimulator from the Ferrule Note Return the explanted Neurostimulator and Leads to NeuroPace NeuroPace will provide shipping containers if requested Flush the craniectomy and Ferrule Open the new Neurostimulator package Note The Neurostimulator is packaged with a temporary white cover over the lead contacts Leave this cover in place until you are ready to attach the Leads to protect the contacts during handling Place the new Neurostimulator in the Ferrule Secure the Neurostimulator to the Ferrule by rotating the Ferrule Clamp into position over the Neurostimulator and tightening the Ferrule Clamp screw until the Torque Driver clicks Figure 12 Note DO NOT use any tools other than the Torque Driver provided to secure the Ferrule Clamp in place Remove the white temporary cover from the Neurostimulator Flush the Neurostimulator connector area if necessary to remove debris and dry area before attaching the new Connector Cover Hold the
47. and the Programmer The SIGNAL QUALITY Q measures the absence of electronic interference in the environment WARNING DRAINING THE NEUROSTIMULATOR BATTERY Testing the Wand placement over the Neurostimulator for more than 10 minutes per day may drain the Neurostimulator battery prematurely INTERROGATING THE RNS NEUROSTIMULATOR Interrogating the RNS Neurostimulator is the act of retrieving the currently programmed settings and any stored data from the Neurostimulator using the Programmer The Wand must be held in place over the Neurostimulator for interrogation to succeed Note After each session during which the Neurostimulator was interrogated by the Programmer it is recommended that the Programmer be synchronized with the PDMS Interrogating the Neurostimulator 1 Goto the Programmer MAIN MENU screen 2 Select the INTERROGATE button Two vertical bars indicate Signal Level S and Signal Quality Q as described in Testing the Wand Signal RNS System User Manual Programming Instructions 56 IMPEDANCE MEASUREMENTS Impedance measurements are useful for verifying the integrity of a particular electrode Each impedance measurement delivers a single pulse of current between an electrode and the Neurostimulator canister can to measure the voltage that results as the current flows Impedance measurements are reported in Ohms voltage divided by current Abnormal impedance values are measurements greater than 3500 O
48. anual Responsive Neurostimulator System 15 PRECAUTIONS SURGICAL Precaution Precaution Precaution Precaution Precaution Connector Plug A vacant port in the Connector Cover must be filled with a Connector Plug provided in the Connector Cover Kit There is an increased risk of Neurostimulator failure if a Connector Cover port is vacant Epidural Lead Placement Leads placed epidurally may cause pain during electrical stimulation Lead Damage Bending kinking and stretching of the Lead may cause Lead damage Handle the Lead with care Sub galeal Lead Placement Wrapping the Lead s on around the Neurostimulator or placing excess Lead near the Neurostimulator may result in Lead damage during subsequent surgical procedures Suture Sleeves Suture Sleeves are provided for use if sutures are used to stabilize the Lead Suturing directly on the Lead may cause Lead body damage and malfunction PRECAUTIONS RNS SYSTEM AND THERAPY Precaution Precaution Precaution Precaution Precaution Afterdischarge Activity If evidence of afterdischarge activity resulting from stimulation is seen either on stored ECoGs or during Test Stimulation delivery stimulation parameters should be adjusted to prevent such occurrence Battery Depletion For continued operation the RNS Neurostimulator needs to be surgically replaced when the battery is depleted Neurostimulator Longevity High and frequent levels o
49. apy options see Table 1 These were Pattern Specific Therapy each detector triggers a different stimulation setting Adaptive Therapy the stimulation frequency adjusts with the ECoG frequency Synchronized Stimulation stimulation is delivered into a specific part of the ECoG waveform and Post Episode Monitoring Post Episode Monitoring Interval responsive therapies are disabled for a specified period of time after detecting the end of the episode Table 1 provides the number and percentage of subjects who were treated with any of the additional stimulation therapy options Table 1 Additional responsive stimulation therapy options Number and 96 of Subjects Programmed Pattern Specific Therapy 29 15 Adaptive Therapy 4 296 Synchronized Stimulation 3 296 Post Episode Monitoring Interval 4 296 Programming the Newly Selected Settings 1 Select the PROGRAM SETTINGS tab 2 Select REVIEW CHANGES to view changes prior to programming 3 Select the PROGRAM button The following can be configured under the ADVANCED SETTINGS button if an ADAPT CHANNEL has been selected on the RESPONSIVE THERAPY main tab Select ADAPTIVE FREQUENCY ON to deliver adaptive therapy such that the pulse to pulse interval p p interval 1 Frequency of the stimulation is a percentage ADAPTIVE of the sensed signal pulse to pulse interval i e the delivered stimulation frequency is proportional to the sensed ECoG signal freque
50. ation Programming the RNS Neurostimulator sends all newly entered information from the Programmer to the Neurostimulator 1 Select the PROGRAM SETTINGS tab 2 Select REVIEW CHANGES to view changes prior to programming 3 Select the PROGRAM button Note ECoG storage triggers are inactive during programming Programming clears activity information and ECoGs stored in the Neurostimulator If there is any new information be sure to interrogate the Neurostimulator prior to programming ASSIGNING LEAD LABELS AND CREATING THE MONTAGE The RNS Neurostimulator can sense brain activity ECoGs from up to four amplifier channels Assigning Lead labels and creating a montage is done using the Programmer If the montage is altered the detection settings that were created with the previous montage are no longer available for use The detection settings will need to be reprogrammed Assigning the Lead Labels 1 Goto the PATIENT PRODUCT tab 2 If not already entered enter the appropriate Lead type and serial number for NEUROSTIMULATOR PORT 1 and NEUROSTIMULATOR PORT 2 RNS System User Manual Programming Instructions 61 Figure 19 RNS Neurostimulator port 1 and 2 locations Port 1 is located towards the center of the Neurostimulator and port 2 is closer to the edge Note Additional Leads implanted may be recorded in the comments field 3 Assign a distinctive label identifying each Lead otherwise a generic LEAD LABEL
51. bleshooting section of this manual AAR WN REPLACING EXPLANTING THE RNS SYSTEM When explanting any part of the RNS System the following disposal quidelines are suggested Return the explanted Neurostimulator to NeuroPace Contact NeuroPace to obtain shipping containers Dispose of all product not returned to NeuroPace by adhering to local governing agency recommendations Do not incinerate or cremate the Neurostimulator Explosion may occur when exposed to extreme heat Replacing the RNS Neurostimulator with a New Neurostimulator 1 2 Using the Programmer disable detection and therapy Verify the position of the Leads to avoid damaging the Leads during incision Verification can be performed using prior x ray or CT imaging Make an incision in the scalp at the incision line used for the initial Neurostimulator implant Note Itis not necessary to explant the implanted Ferrule when replacing the Neurostimulator however the Ferrule Clamp may be replaced RNS System User Manual Surgical Procedures 50 4 10 11 12 13 14 15 16 17 18 19 20 Clear tissue and bone debris away from the area surrounding the Neurostimulator and Lead Strain Relief area Remove the upper Lead Strain Relief from the Neurostimulator and dispose of the old Lead Strain Relief Use the Torque Driver to loosen and remove the Connector Cover Remove the proximal Lead ends from the Connector Cover M
52. can also be used to detect spiking activity such as the activity shown in the second example AA AMA m A uh AA au A f BETERA n Aw Wh S T A wel p d A aN yoy NN Www y Mg Wage MI i A A K ana dl Fo dl N M A A AN n Ar nth N NI NM ih hi IA IMP d AM ni PL Mak Mn JJ TA aw t vi ni ew Ai A A NT MV LAN VP s Ln AAN A IM mA VOU PAW A WA LV E wd MP Hl di J AAR An T l Wi M FO IV W Ww yi W ul WY p y y Hh if PN Y J VN m l N Fg i 4 Vv i HI I i I Figure 31 Examples of types of electrographic activity that can be detected by the Bandpass detector Detection settings should be programmed for early detection of activity Detection settings that result in early activity detection usually also result in numerous detections this is expected and acceptable behavior e Evaluate DETECTOR CHANNELS e After several stereotypical ECoGs with activity have been stored the DETECTOR CHANNELS may need to be changed to those that capture the earliest activity e Adjust LINE LENGTH detector settings Figure 32 e The Line Length DETECTION THRESHOLD may be adjusted to improve specificity and sensitivity Decreasing the percentage will result in earlier but more frequent detections increasing the threshold percentage will have the opposite effect e Decreasing the SHORT TERM TREND from 4 to 2 seconds also gives earlier more frequent detections This adjustment allow
53. d Waveforms BEES 62 50 Hz Sinusoid Minimum Duration Settings Selection Mode Clinical Navigation Display Options Timebase Seconds M Waveform V Device Markers m m m mmm ES TET Spectrogram Minor Grid J Detection Features 1 ength vvailable T 30 60 v Entire ECoG CU Du First Detector Second Detector Figure 33 Bandpass tab Programming the Newly Selected Detection Settings 1 Select the PROGRAM SETTINGS tab 2 Select REVIEW CHANGES to view changes prior to programming 3 Select the PROGRAM button RNS System User Manual Programming Instructions 75 SETTING UP RESPONSIVE THERAPY The RNS Neurostimulator can deliver a Therapy Sequence of up to 5 individually configured therapies in response to detected activity The Neurostimulator resumes sensing after each therapy is delivered If the activity is still detected the next sequential therapy is delivered If the activity is no longer detected the remaining therapies are not delivered and the episode ends The therapy sequence refreshes with the detection of each new episode Note It is recommended to review and perform detection analysis prior to enabling responsive therapy Behavior for the first therapy in the therapy sequence may be configured in one of two ways e Different bursts may be delivered in response to a specific event detector Pattern A or Pattern B as depicted in Figure 34 or e Up to two bursts may be selected to be delive
54. d be aware of possible sensing artifacts when assessing the ECoG recordings Potential sources of RFID may occur in a health care environment retail stores public libraries airports and business environments Refer to Electromagnetic Emissions and Immunity for more information RNS System User Manual Responsive Neurostimulator System 13 WARNING WARNING SECURITY AND ELECTRONIC TRACKING SYSTEMS Security screening devices such as theft detectors and airport security screening devices can result in signals that appear as ECoG activity to the Neurostimulator Signals that appear as ECoG activity could also result in delivering the programmed stimulation to the patient per the device detection programming Such devices may be found at retail stores public libraries and airports The physician should be aware of possible sensing artifacts when assessing the ECoG recordings Patients should be instructed to walk through the center of such security screening units without stopping when possible and exit the area of the screening device as soon as possible Refer to Electromagnetic Emissions and Immunity for more information INTERACTION WITH IMPLANTED CARDIAC DEVICES Possible effects of implanted device interaction with an implanted cardiac device e g pacemaker or defibrillator include the following e Defibrillation therapy from an implanted defibrillator may damage the device e The electrical pulses from the neurostimula
55. delay programmed delay in the delivery of the first pulse of a burst measured from the time of synchronizing to a signal peak First pulse synchronization Delivering the first pulse in a burst or after a first pulse delay Synchronous from a peak in an ECoG signal Fixed pulse interval The fixed pulse interval is a setting available for each responsive therapy burst Fixed pulse intervals are delivered at the same frequency each time a therapy is delivered Frequency The frequency is the rate at which pulses are delivered which is expressed in Hz pulses second Impedance measurement The opposition of current flow between electrodes as determined by measuring the voltage Ohms resulting from the delivery of a current pulse A current pulse must be applied to the patient in order to obtain this measurement Implant configuration Information which describes the port s to which the proximal end of the Lead s are connected Interactive Session A programming session that follows interrogation of the Neurostimulator Interrogate The act of retrieving stored data and settings from the Neurostimulator using the Programmer Lead Cap The Lead Cap is intended to physically protect the proximal ends of implanted Leads that are not connected to the Neurostimulator Lead label Numerical and or alpha characters assigned to a Lead to describe its anatomical location Lead Strain Relief The Lead Strain Relief is intended to mechanicall
56. e Connector Cover must be filled with a Connector Plug provided in the Connector Cover Kit There is an increased risk of Neurostimulator failure if a Connector Cover port is vacant Situate all capped unconnected Leads adjacent to the Neurostimulator to facilitate easy connection to the Neurostimulator in the future Place any excess lead length in a sub galeal pocket near the craniectomy away from the incision line Note Leave sufficient slack in the Lead adjacent to skull fixation points to relieve stress on the Lead Cover the Programmer Wand with a sterile bag and position it over the Neurostimulator Record the Lead information serial number s and corresponding Neurostimulator port number s on the PATIENT PRODUCT tab of the Programmer Select the desired amplifier sensing channels on the MONTAGE tab under CONFIGURE SETTINGS of the Programmer Program the information into the Neurostimulator RNS System User Manual Surgical Procedures 54 23 View real time ECoG signals on the REAL TIME ECoGs tab under REVIEW DATA tab and measure Lead impedance s under MEASUREMENTS tab to ensure proper connection between the Neurostimulator and the Leads If impedance measurements are abnormal or real time ECoG signals are not adequate remove the Connector Cover and flush the connector area Fully reinsert the leads into the Connector Cover and repeat the impedance measurements Refer to Troubleshooting Section if impedance
57. e RNS System be powered from an uninterruptible power supply or a battery Power frequency 50 60 Hz magnetic field IEC 61000 4 8 3 A m 3 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment The RNS System is intended for use in the electromagnetic environment specified The customer or the user of the RNS System should assure that it is used in such an environment RNS System User Manual U is the a c mains voltage prior to application of the test level Specifications 96 Table 4 Guidance and manufacturer s declaration electromagnetic immunity for equipment and systems that are not life supporting Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 Radiated RF IEC 61000 4 3 3 Vrms 150 KHz to 80 MHz 3 V m 80 MHz to 2 5 GHz 3V 3 V m Portable and mobile RF communications equipment should be used no closer to any part of the RNS System including cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended separation distance d 1 17VP d 1 17VP 80 MHz to 800MHz d 2 33 P 800 MHz to 2 5 GHz Where P is the maximum output power rating of the transmitter in watts W accordi
58. e cleaned by wiping with water It can be placed in a sterile bag for use in the sterile field DO NOT STERILIZE the Wand Electrostatic Discharge ESD Static Electricity The ports on the Programmer Laptop may be sensitive to electrostatic discharge ESD static electricity Handle the Programmer Laptop ports carefully If exposed to electrostatic discharge the Programmer may experience telemetry artifacts or errors or may freeze In the event of a Programmer freeze refer to the Troubleshooting section RNS System User Manual Responsive Neurostimulator System 27 RNS SYSTEM LONGEVITY RNS Neurostimulator Battery Neurostimulator longevity depends on the amount of stimulation delivered to the patient Each time the Neurostimulator delivers stimulation a small amount of charge is drained from the battery The battery information for each Neurostimulator can be obtained through the PDMS Battery measurements can be taken using a Programmer RNS Neurostimulator Battery Life Estimation for Model RNS 300M The following battery information is theoretical In actual use the programmed stimulation parameters and other factors such as Lead impedance may vary Therefore the following battery longevity estimates from beginning of battery life to end of service were calculated utilizing three patient use profiles Low 5th Percentile Medium 50th Percentile and High 95th Percentile It is important to note that the RNS Neuro
59. e damaged or malfunction if the Programmer AC adapter and power cord are not properly connected to a grounded power source PRECAUTIONS MEDICAL ENVIRONMENT Precaution Precaution Medical Procedures Patients should always inform any healthcare personnel that they have an implanted RNS System and show their Medical Implant Identification Card before any procedure is performed Advise the patient to contact their healthcare provider as soon as possible if they have questions or suspect their device is not functioning properly after any medical procedure Electrocautery The use of electrocautery electrosurgery can affect the operation of neurostimulators The RNS System has been designed to prevent or minimize the effects of electrocautery however the energy levels used in electrocautery can temporarily interfere with or cause permanent damage to device operation Electrocautery applied near the RNS Neurostimulator may cause it to temporarily stop sensing delivering therapy or may reset the Neurostimulator Under these conditions the Neurostimulator may require interrogation and possible reprogramming Electrocautery applied directly to the Neurostimulator or Leads may couple enough energy into a neurostimulator system to damage brain tissue If electrocautery is necessary the following recommendations may be effective in minimizing potential complications Before the procedure e If possible temporarily disable sti
60. e focus it is possible that the seizure focus will not be adequately treated Therefore it is essential that the seizure focus be sufficiently well localized to guide placement of the Lead or Leads Localization of the seizure focus is accomplished using standard localization tests available at qualified Comprehensive Epilepsy Centers This will always include in patient video EEG monitoring with scalp electrodes with or without supplemental electrodes such as sphenoidal electrodes as well as MRI with appropriate magnet strength and sequences for the detection of mesial temporal sclerosis and other common epileptogenic lesions Non invasive EEG and MRI imaging may be adequate to determine the number and location of seizure foci However some patients may require additional testing with video EEG monitoring with intracranial electrodes to identify or refine the localization of the seizure focus This may also include intraoperative or extraoperative stimulation with subdural electrodes for functional cortical mapping Additional imaging studies may include Positron Emission Tomography PET ictal single photon emission computed tomography SPECT functional MRI fMRI or magnetoencephalography MEG Neuropsychological testing and intracarotid amytal Wada testing is included in many Comprehensive Epilepsy Centers localization evaluation Patients with medically refractory partial epilepsy following resective surgery should have had appropriate s
61. e implantation of subdural and stereotactic implantation of intraparenchymal electrodes and in the surgical treatment of intractable epilepsy The RNS System should only be used by neurologists or neurosurgeons with adequate experience in the management of intractable epilepsy and in the localization of epileptic foci including the use of scalp and intracranial electrodes Neurologists and neurosurgeons using the RNS System must have completed the NeuroPace RNS System training program To qualify to manage patients with the RNS System physicians must demonstrate specific expertise related to epilepsy video EEG monitoring interpretation of electrocorticograms ECoGs the pharmacology of antiepileptic medications and selection of patients for epilepsy surgery Implantation of the RNS System should be performed only by qualified neurosurgeons at centers capable of providing comprehensive epilepsy care i e Comprehensive Epilepsy Centers These centers should have the expertise to provide diagnostic services that include video EEG monitoring with scalp and intracranial electrodes and neuroimaging and are experts in the treatment of epilepsy with antiepileptic medications epilepsy surgery and devices MANAGEMENT OF PATIENTS WITH THE RNS SYSTEM BY PHYSICIANS AT CENTERS THAT DO NOT PROVIDE THE SERVICES PROVIDED AT COMPREHENSIVE EPILEPSY CENTERS In some instances post implant programming may be conducted by neurologists meeting the expe
62. e scalp from to the craniectomy Instructions for implanting NeuroPace Depth and NeuroPace Cortical Strip Leads are provided in the Surgical Procedures section When the implantation procedure is complete and while still in the operating room the Programmer is used to test Lead impedances and to capture real time ECoG to ensure that there is good lead tissue contact Instructions for checking Lead impedances and for real time ECoG are provided in the Impedance Measurements section and the section describing Capturing Real time ECoGs Recommended Initial Detection and ECoG Storage Settings The Neurostimulator is initially programmed in the operating room to detect electrocorticographic activity ECoG and to store ECoG segments A bipolar electrode montage is used for sensing The sensing montage must be configured in a bipolar manner The recommended initial montage is to sense between neighboring contacts For RNS System User Manual Clinical Use of the RNS System 31 example channel 1 should be programmed to sense the difference between electrode 1 on Lead 1 and electrode 2 on Lead 1 The recommended initial detection settings are the default settings in the Programmer These settings detect changes in frequency and power of the ECoG line Length detector with a 75 threshold The Neurostimulator is programmed to store segments of the ECoG when specific events occur The physician selects which types of events trigger ECoG sto
63. e the e NeuroPace Programmer Laptop computer with proprietary software and telemetry component Wand Model W 02 used for communication with the implanted RNS Neurostimulator e NeuroPace Patient Data Management System PDMS used for storage and access to historical Neurostimulator and patient data RNS System User Manual Responsive Neurostimulator System 20 e NeuroPace Remote Monitor Laptop computer with proprietary software and telemetry component Wand Model W 02 used by the patient to gather information from the implanted RNS Neurostimulator and upload it to the NeuroPace Patient Data Management System For additional information refer to the Remote Monitor User Manual e Magnet used by the patient to withhold therapy or to trigger electrocorticographic ECoG storage Cortical Strip Lead e e Lead Strain Relief e Depth Lead Connector Cover Figure 2 RNS Neurostimulator with two NeuroPace Leads RNS System User Manual Responsive Neurostimulator System 21 Theory of Operation The RNS Neurostimulator and implanted intracranial Leads are designed to monitor electrical activity of the brain and deliver therapy in the form of electrical stimulation when appropriate The Neurostimulator is implanted in the patient and communicates with the Programmer and Remote Monitor Patient Data Management System PDMS PC Programmer or Remote Monitor Wand Telemetry zj
64. eaes 60 Assigning the Lead Labels ride e d apri t deese 60 Recommended Initial Lead Labels sss eis estne enitn th naeh nnn 62 Creating a Montage s sse Le ide adea p a eds eret opes udo ede 63 Recommended Initial Montage settings sss enses tnnt 63 Programming the Newly selected Settings sss 64 SETTING UP ECOG STORAGE eon er etr Aimer e ro e da o aep eta Pere pr Yd er rats Du Ree x VL ete tune dn 64 Selecting ECOG Storage Settings sss essen einn tnn nennen 64 Recommended Initial ECOG Storage Settings sss 65 Recommended Modifications to ECOG Storage Settings sess 67 Programming the Newly Selected ECoGs Storage Settings sss 68 SEATING UP DETECTION sisi het ee op eat et med mq inui A ape Ree E Re uade 69 Enabling Disabling or Changing the Detection Settings sss 69 Recommended Initial Detection Settings sisse sienne 70 Recommended Modifications to Detection Settings sese 70 Programming the Newly Selected Detection Settings senes 74 SETTING UPR RESPONS VE THERAPY 4 2i the ete t Re fe b eek ashe eee ERR PP e ae ste Ren eden 75 Enabling Disabling or Changing Responsive Therapy sss 76 Recommended Initial Responsive Therapy Settings eene 77 Recommended
65. ective replacement indicator is displayed upon interrogation of the Neurostimulator The Neurostimulator should be replaced promptly after the ERI notification The ERI indicator is displayed approximately three months prior to the Neurostimulator end of service see below End of Service EOS End of service is the point at which the RNS Neurostimulator is no longer guaranteed to meet its specifications The Neurostimulator resets and no longer detects or stimulates within one week of EOS detection The Programmer can be used to indicate when the EOS battery level has been reached RNS Neurostimulator Reset When the Neurostimulator resets all of the Neurostimulator functions are suspended except telemetry and battery measurement functions The Neurostimulator does not detect or deliver stimulation measurements are disabled except battery and no records are stored The Neurostimulator resets if an internal problem is detected or the Neurostimulator battery voltage is at End of Service The Programmer notifies the user of a reset upon Neurostimulator interrogation RNS Neurostimulator Inactive The sterile packaged Neurostimulator is shipped in an inactive state during which all Neurostimulator functions are suspended except telemetry and battery measurement functions The Neurostimulator does not detect or deliver stimulation measurements are disabled except battery and no records are stored The first interrogation of a sterile
66. eee 5 RNSUSYSTEM Joins ea ac ecd dier hal NL DM e od aa 9 INDICATIONS C ade cielatnae inteelts end E idee ade ented alias 9 CONTRAINDIGATIONS 2 27 45 Adee etre cti RU ech RE E den le ER EE Dente EE dee e P PB ed S 9 WARNINGS AND PRECAUTIONS 13 oie EE en e tee ER gei Ee ee Ene eee eee idee De d dd deae edu Pob aede aada 10 IMPLANTED INS SYSTEM mcis naciet adstat ee topo e LU EA Ee a ESAE 19 RNS SYSTEM DESCRIPTION Juil c cei UA Tow uA ee RR DHL A Dra iscin3 RA 19 PINS NEUSOSEMUBATOR 0 45 totasedchf t esent imde us fot ede rum de uM E I Ee E 22 RNS SYSTEM COMPONENTS AND ACCESSORIES eeeete tentent tnter te teet testo tetas 22 NEUROPACE CORTIDAISSTRIPIEBAD seii ad adim dts iroate diosicledlina rad Esc rase M ip AL 23 NEUROPAGE BEPTHIBEADs n mccusdint oso a tdeo a a cp LR i MI D ANENG 23 LEAD COMPONENT AND ACCESSORIES 3 dur gi festo set e Free re led ger tees 24 NEURGPACE PROGRAMMER mentecdieitia masas duet ttt entar enda ste Letra M cn UM E 24 TELEMETRY WAND aite eet D En EL De CEDE IH an HEUTE e ot ee Fe et Meese e 25 NEUROPACE PATIENT DATA MANAGEMENT SYSTEM tette teretes 25 STERILIZATION STORAGE AND HANDLING sssssseseseeeeneeene eene nennen enne tn rennen en nnne nn nennen 26 PRINS SYSTEM LONGEVIV naea ta crate dy nti enced ee Luce aera a 27 PRODUCT REGISTRATION 22 2 sort ieri do dest ta Een ceret Poo estt qute Sed ate deer Me rte iet M edhe 28 CLINICAL USE OF THE RNS SYSTEM ssscsssssesssssessess
67. ength of the signal within a given time period This compares the most recent Line Length measurement to past line length measurements Therefore the Line Length detector can detect changes in the signal amplitude and or in signal frequency RNS System User Manual Programming Instructions 71 Two examples of the types of electrographic patterns that could be detected using the Line Length detector are provided in Figure 29 In the first example the amplitude of the signal increases In the second example the frequency of the signal increases Both of these types of signal changes result in a change in the Line Length and therefore can be detected by the Line Length detector The shaded boxes represent the activity detected Because the Line Length detector is sensitive to both amplitude and frequency changes the Line Length detector is often used as the initial detector to detect any large change in the signal Once an electrographic pattern is selected for detection other detector types may be used to provide more specific detections n A i 1 A 1 4 hd Ala ALI fudit NI Nat vet i wh ila n py n ANI m Arve ETT My WI TE 2 MI M h 7 f r JN nA s HW T 4 Kaa VE py M m n i FNIT Mh Aul LN i Y Miah A Aubl li ii AUN T A el iM N Ih JA A PR EN E TA IMP TNI NAA ANT d Figure 29 Examples of types of electrographic activity that can be detected by the Line Lengt
68. enter hyperbaric chambers above 2 0 atmospheres absolute ATA Such pressures could damage the system Patient Population for which safety and efficacy have not been established The safety and effectiveness of the device has not been established for the following e Patients with generalized epilepsy Patients with a seizure focus that cannot be adequately localized Pregnant women Nursing mothers Less than age 18 Patients with simple partial sensory seizures only Patients with less than three seizures a month on average Patients who have more than two epileptic foci Patients who have not failed two antiepileptic drugs Safety and Effectiveness beyond 24 months The safety and effectiveness of the RNS System beyond 24 months is unknown RNS System User Manual Responsive Neurostimulator System 19 IMPLANTED RN s SYSTEM Figure 1 The Implanted RNS System RNS SYSTEM DESCRIPTION The RNS System automatically delivers responsive electrical stimulation to reduce the frequency of partial onset seizures Note that the RNS System is not a seizure detection device The RNS System comprises sterile implantable and non sterile external products Implantable RNS System Products The sterile implantable products are the e RNS Neurostimulator e NeuroPace Cortical Strip Lead s and NeuroPace Depth Lead s e Implantable components and accessories External RNS System Products The non sterile external products ar
69. essesscssesscssesesssesesssesssssessssnsecsscsacsscsessnesecsseseeess 29 IDENTIFYING CANDIDATES FOR THE RNS SYSTEM THERAPY 29 LOCALIZING THE SEIZURE FOCUS AND PLANNING LEAD LOCATION sseeeeeeeneeeee nee 29 PATIENT TRAINING 6th ertet perte e e rH RU UR viet de ae adn CHEER BE epe tds 30 OVERVIEW OF IMPLANTATION AND PROGRAMMING OF THE RNS SYSTEM seees 30 Implanting the RNS Neurostimulator and Leads 30 Recommended Initial Detection and ECOG Storage Settings sss 30 Recommended Initial Responsive Therapy Settings sse 31 Modifying Detection and Responsive Therapy Settings sse 32 SURGICAL PROCEDURES Lene tie t cie rie arana Leech bo cinere Diae AL REL Rock Ek io raura ed 33 PRE IMBPEANT 2 nr estote emma tee eec iet roi pt le ets 33 RECOMMENDED IMPLANT PROCEDURE FLOW CHART ceccceeeceeceeeeeeeeeeeeecaeecaeecaaeceaeecacesaaesaeseaeeeeesanenteees 36 RECOMMENDED NEUROPACE DEPTH LEAD IMPLANTATION AND FIXATION ees 37 RECOMMENDED NEUROPACE CORTICAL STRIP LEAD IMPLANTATION AND FIXATION es 40 RECOMMENDED RNS NEUROSTIMULATOR IMPLANTATION PROCEDURE eenes 41 CONNECTING THE RNS NEUROSTIMULATOR TO THE IMPLANTED LEAD S ees 45 REPLACING EXPLANTING THE RNS SYSTEM 5 cien centes teda rdg eei cie rod rerba ge d 49 CHANGING THE LEADS THAT ARE CONNECTED TO THE NEUROSTIMULATOR seeeeeee ees 52
70. esult in incomplete communication If EMI disrupts programming move the Programmer away from the likely source of EMI Refer to the Poor or No Communication between the Programmer and the Neurostimulator section for more information Placement of the Programmer Power Cords Make sure nothing rests on the Programmer power cable and that the cable is not located where it can be tripped over or stepped on Heating The Programmer AC adapter and the bottom of the Laptop computer may become hot during normal operation Use care when handling the adapter during or immediately after operation PRECAUTIONS HOME OR OCCUPATIONAL Precaution Precaution Precaution Precaution Precaution Keep Magnets at least 4 inches Away from the Implanted RNS Neurostimulator Magnets that are contained in such products as stereo speakers AM FM radios power tools cellular cordless and conventional phones as well as magnets used therapeutically or worn on the body should be kept at least 4 inches away from the Neurostimulator The Neurostimulator may not deliver stimulation while these magnets are closer than 4 inches Most headsets and earphones available in stores do not interfere with the RNS System but not all have been tested Magnet Use care when handling the Magnet as it may break if dropped and the broken pieces may have sharp edges Scuba diving or hyperbaric chambers Patients should not dive below 10 meters 33 feet of water or
71. ews ECoGs that are stored on the PDMS or Programmer The physician decides whether the detection settings should be modified based on the ECoG review In addition to the Line Length detector the Neurostimulator has Bandpass and Area detectors described in the section titled Setting up Detection If the physician wishes to change which ECoG patterns are detected the detectiors may be adjusted or a different detection tool may be selected For example if the physician wishes to detect smaller changes in the ECoG amplitude the Line Length detector can be programmed to be more sensitive If the physician wishes to detect specific ECoG frequencies the Bandpass detector could be used Different detection settings can be simulated on the ECoG segments that have been stored on the PDMS or Programmer This allows the physician to see how the modified detection settings perform before deciding to program these settings into the Neurostimulator Instructions for modifying detection settings are provided in the section titled Setting up Detection The physician may choose to modify stimulation to improve the patient s clinical response Although modifications can be made to the stimulation frequency burst duration or pulse width it is recommended that initial modifications be to increase the current amplitude by 0 5 mA increments with each stimulation setting tested using the Therapy Testing function to ensure that it is well tolerated by the patient a
72. f stimulation reduce Neurostimulator battery longevity Draining the Neurostimulator Battery Testing the Wand placement over the RNS Neurostimulator for more than 10 minutes per day may drain the Neurostimulator battery prematurely Frequency of Remote Monitoring The patient should interrogate the RNS Neurostimulator with the Remote Monitor and Wand daily and synchronize the Remote Monitor with the PDMS at least once a week RNS System User Manual Responsive Neurostimulator System 16 Precaution Precaution Explantation and EMI Considerations If any system components Neurostimulator Leads Lead fragments or cranial prosthesis remain implanted in the patient after a partial system explant the patient is still susceptible to possible adverse effects from strong sources of EMI It is possible for the interference sources to couple enough energy into a neurostimulator system to damage brain tissue resulting in serious patient injury or death Patients who have system components implanted should exercise caution in avoidance of devices which generate a strong electric or magnetic field Refer to Electromagnetic Emissions and Immunity for more information Lead Replacement and Abandoned Leads The long term safety associated with Leads left in place without use replacement of Leads and Lead explant is unknown PRECAUTIONS PROGRAMMER Precaution Programmer Failure As with any electronic device the Programmer may b
73. g from stimulation is seen either on stored ECoGs or during Test Stimulation delivery stimulation parameters should be adjusted to prevent such occurrence RNS System User Manual Programming Instructions 8 Eg EH BB Ee Figure 36 Therapy Testing screen RNS System User Manual Programming Instructions 9 e Suggested initial responsive therapy settings In general stimulation should be delivered to the leads and electrodes from which the activity of interest is observed Program BURST 1 for electrodes on one Lead Program BURST 2 for electrodes on the other Lead Program CURRENT to 1 0mA Other parameters should be left at their default values e FREQUENCY 200 Hz e PW PER PHASE 160 ps e BURST DURATION 100 ms Copy THERAPY 1 settings to THERAPY 2 through THERAPY 5 Program settings into the Neurostimulator on the PROGRAM SETTINGS tab Configure Settings Test Stimulation Montage Y Detection ECoG Storage Responsive Therapy l Responsive Tx Main Therapy 1 Therapy 3 Therapy 5 LHip1 LHip2 LHip3 LHip4 PHip1 RHip2 RHip3 RHip4 Electrode h Burst 1 Electrode Burst 2 Current 1 0 mA LHip1 Current 1 0 mA Frequency 200 0 Hz 5 ms LHip2 Frequency 200 0 Hz 5 ms PW Per Phase 160 us LHip3 PW Per Phase 160 us Burst Duration 100 ms LHip4 Burst Duration 100 ms Estimated RHip1 Estimated Charge Density
74. ged Neurostimulator 1 Turn on the Programmer and login as NPUser 2 Place the Wand over the Neurostimulator which is visible from the bottom clear side of the Neurostimulator sterile packaging tray Select the INTERROGATE button on the Programmer MAIN MENU screen Review MEASURED BATTERY VOLTAGE on the Summary screen If interrogation fails or the battery voltage is 2 85 V return the Neurostimulator to NeuroPace and continue the procedure with another sterile packaged Neurostimulator To manually measure battery voltage after interrogating 1 Goto the REVIEW DATA tab 2 Select the MEASUREMENTS tab 3 Select the MEASURE button in the Battery section of the MEASUREMENTS tab screen Opening the Sterile Product Package Prior to opening the sterile packaging inspect for any damage or breach in package seal integrity If the packaging appears to be wet punctured or damaged the contents may no longer be sterile Product s with damaged packaging should be returned to NeuroPace for replacement Packages containing sterile product s should be opened into a sterile surgical field Products should not leave the sterile surgical field once the package is opened Figure 6 Handing the sterile product tray to a surgeon in the sterile field RNS System User Manual Surgical Procedures 35 Bone screws It is recommended that 1 5 mm diameter 4 mm long bone screws not provided be used to secure the Ferrule to the skull
75. gth in seconds of stored ECoGs 120 second 60 second Pre trigger Post trigger ECoG Triggering Event Detected 3 minute ECoG record Figure 23 Illustration of a stored ECoG with a 120 second pre trigger and a 60 second post trigger period 5 Select the ECoG storage TRIGGERS that will initiate storage of an ECoG e LONG EPISODES triggers initiate ECoG storage when a detected episode continues beyond a preset duration LoNG EPISODE LENGTH This trigger can be used whenever detection is ENABLED e PATTERN A and PATTERN B triggers initiate ECoG storage when an episode beginning with a characteristic pattern Pattern A or Pattern B is detected Selecting one of these RNS System User Manual Programming Instructions 65 triggers may be helpful in evaluating the detection setting parameters These triggers can be used whenever detection is ENABLED e RESPONSIVE THERAPY triggers initiate ECoG storage when electrical stimulation therapy is delivered in response to a detected event Selecting this trigger may be helpful in determining if therapy was delivered appropriately as well as evaluating the result of the therapy delivered This trigger can be used whenever responsive therapy is ENABLED e NOISE triggers initiate ECoG storage when a 60 Hz signal is detected in the ECoG signal Selecting this trigger may be helpful in troubleshooting the RNS System This trigger can be used whenever detection is ENABLED e SATURATION
76. h detector Area detector The Area detector detects changes in signal power This detector works by measuring the area under the curve which is the area between the ECoG signal and the x axis Similar to the Line Length detector the Area detector compares the most recent measurement to past measurements An example of the type of electrographic pattern that could be detected using the Area detector is provided in Figure 30 where the signal amplitude or power increases Unlike the Line Length detector the Area detector is not sensitive to changes in the signal frequency It is only sensitive to changes in the power Van P Ha Ns N PEIN Apa PA a ANNAA a Dow S AA NM nfi a A IN Figure 30 An example of the type of electrographic activity that can be detected by the Area detector RNS System User Manual Programming Instructions 2 Bandpass detector The Bandpass detector provides highly specific and early detection of rhythmic and spiking activity This detector provides more specific detection than the Line Length and Area detectors The Bandpass detector acts like a frequency filter and can therefore be used to detect activity within specific frequency bands e g theta alpha beta and gamma Two examples of the types of activity that can be detected using the Bandpass detector are provided in Figure 31 In the first example the Bandpass detector detects highly rhythmic beta activity The Bandpass detector
77. he Cranial Prosthesis to the Ferrule by rotating the Ferrule Clamp into position over the Cranial Prosthesis and tightening the Ferrule Clamp screw until the Torque Driver clicks Place proximal Lead end s in a sub galeal pocket Close the incision CHANGING THE LEADS THAT ARE CONNECTED TO THE NEUROSTIMULATOR This section provides instructions for changing which Leads are connected to the RNS Neurostimulator The steps found in this section assume the Leads are already implanted In order to change the Lead connection the Lead s currently connected to the Neurostimulator must first be disconnected from the RNS Neurostimulator Changing Lead connections 1 2 Using the Programmer disable detection and therapy Verify the position of the Leads to avoid damaging the Leads during incision Verification can be performed using prior x ray or CT imaging Make an incision in the scalp at the incision line used for the initial Neurostimulator implant Clear tissue and bone debris away from the area surrounding the Neurostimulator and Lead Strain Relief area Remove the upper Lead Strain Relief from the Neurostimulator and dispose of the old Lead Strain Relief Use the Torque Driver to loosen and remove the Connector Cover RNS System User Manual Surgical Procedures 53 T 10 11 12 13 14 15 16 17 18 19 20 21 22 Remove the proximal Lead end s from the Neurostimulator port
78. he Lead may cause Lead damage e Donotreinsert stylet into the Lead once it has been removed e Donottighten sutures over the Lead body e Only use the Torque Driver to secure the Connector Cover Resterilization of Implantable Products The RNS Neurostimulator is provided sterile DO NOT RESTERILIZE Implantable RNS System products are single use only Do not resterilize or re implant any explanted products of the RNS System Return the explanted Neurostimulator and Leads to NeuroPace Use by Date Do not implant or use any system component after the Use by date Return all such product to NeuroPace Damaged Packaging Prior to product use inspect the sterile packages for seal integrity If the packaging appears to be wet punctured or damaged the contents may no longer be sterile and these product s should be returned to NeuroPace for replacement Product Storage Components should be stored in a clean and secure area with a room temperature of approximately 14 to 28 degrees Celsius Explant and Disposal Program all detection and therapy functions to DISABLED prior to explanting and shipping the RNS Neurostimulator Return the explanted Neurostimulator and Leads to NeuroPace NeuroPace will provide shipping containers if requested DO NOT incinerate the Neurostimulator explosion can occur if the Neurostimulator is exposed to incineration or cremation temperatures Wand Cleaning and Sterilization The Wand can b
79. he amount of time stored for a Programmer commanded ECoG record ECoG retrieval Recovery of ECoG records from the Neurostimulator memory Retrieving ECoGs clears the records from Neurostimulator memory and stores them in Programmer memory RNS System User Manual Glossary 103 ECoG storage trigger The type of Neurostimulator activity selected by the user to result in the storage of an ECoG record if the activity occurs Elective replacement indicator ERI The ERI indicator is displayed on the Programmer to notify the user that the Neurostimulator is approximately three months prior to end of service EOS Neurostimulator elective replacement is suggested at a battery voltage equal to the ERI End of service EOS End of service is the point in service at which the battery level is still sufficient to allow operation however some features may be lost Episode duration The time elapsing between the point at which the Neurostimulator detects Pattern A or Pattern B to the point at which post episode baseline activity is detected Event Activity detected by the Neurostimulator Events are considered any of the following Long Episodes Pattern A Pattern B Responsive Therapy Noise or Saturation Ferrule The Ferrule is intended to be installed in a craniectomy to secure and mechanically support the Neurostimulator in the cranium Ferrule Clamp The Ferrule Clamp is used to secure the Neurostimulator to the Ferrule First pulse
80. hms or less than 250 Ohms If impedance measurements are abnormally high there may be insufficient charge to deliver therapy Refer to the Troubleshooting section of this manual for additional information on abnormal impedance measurements Measuring Impedances between Electrodes and the Can Each Electrode to the Neurostimulator 1 Position the Wand over the Neurostimulator Go to REVIEW DATA tab Select the MEASUREMENTS tab Select the CURRENT to be delivered Select ANODE or CATHODE for the Neurostimulator can DY OY Be O NS Select the MEASURE button to deliver the single pulse of current Note After the impedance measurements are performed it is recommended to repeat the measurement with opposite polarity Note The Neurostimulator cannot measure impedance while an episode is being detected or during any type of therapy delivery Disable detection and or therapies or wait for a detected episode or therapy delivery to finish in order to continue with a successful impedance measurement BATTERY VOLTAGE MEASUREMENTS Normal RNS Neurostimulator battery voltage measurements are between 2 70 and 3 10 Volts When the battery voltage measurement drops to 2 75 Volts or less Neurostimulator replacement is recommended Measuring the Battery Voltage 1 Go to REVIEW DATA tab 2 Select the MEASUREMENTS tab 3 Select the MEASURE button CAPTURING Real time ECoGs Real time ECoG capture is useful in evaluating the ECoG signals
81. ics To reduce the risk of infection it is recommended that antibiotics be administered prior to surgery Product Preparation 1 Order and obtain the RNS Neurostimulator and appropriate Lead s for the implant as determined in the surgical planning for this procedure 2 Before opening the RNS Neurostimulator and Leads packaging verify model numbers use by dates and product sterility 3 It is recommended that additional products be available in case product sterility or function is compromised Number of Leads A maximum of four Leads may be implanted only two of which may be Depth Leads Only two Leads may be connected to the Neurostimulator at any time it is recommended that a unique identifier be attached to each Lead Programmer Preparation The Programmer should be in the operating room It is used for the following activities e Assigning Lead type s and serial number s to the corresponding Neurostimulator port s e Programming the Montage Detection and ECoG storage e Confirming Lead integrity by performing Lead impedance measurements e Viewing real time ECoGs to verify sufficient lead tissue contact e Troubleshooting Neurostimulator and Lead issues RNS System User Manual Surgical Procedures 34 Pre Implant RNS Neurostimulator Interrogation The sterile packaged Neurostimulator should be interrogated using the Programmer prior to implantation to verify battery voltage To interrogate the sterile packa
82. iectomy Template is intended to be used as a pattern to mark and delineate the shape of the Ferrule on the skull prior to making the craniectomy Current The amplitude of current that will be delivered in each phase of a current pulse Depth Lead The Depth Lead is intended for implant into deep brain structures to provide an interface through which electrical activity of the brain can be monitored and electrical stimulation may be delivered Detector channel The amplifier channel of electrodes selected to detect ECoG activity Detection settings Settings that combine Patterns and Detection Tool settings in order to detect activity Detection status A detection setting that controls the current state of the Neurostimulator detection function Detection may be DISABLED meaning detection is not active or ENABLED meaning the Neurostimulator detection function is active and will monitor the sensed ECoG signal for events Detection tools There are three 3 types of detection tools selectable for Pattern A or Pattern B event detectors The detection tools are the Bandpass Tool Line Length tool and Area tool ECoG Electrocorticogram Electrical activity derived directly from the cerebral cortex Also used to describe the Neurostimulator or Programmer stored record of this activity e g ECoG record ECoG activity ECoG activity refers to activity which is detected by the Neurostimulator using one of the event detectors ECoG Length T
83. imulator sends all newly selected settings from the Programmer to the Neurostimulator The PROGRAM SETTINGS tab is the only location on the Programmer from which new settings can be programmed into the Neurostimulator 1 Select the PROGRAM SETTINGS tab 2 Select REVIEW CHANGES to view changes prior to programming 3 Select the PROGRAM button Note ECoG storage triggers are inactive during programming Programming clears activity information and ECoGs stored in the Neurostimulator If there is any new information be sure to interrogate the Neurostimulator prior to programming SETTING UP ECOG STORAGE Electrocorticograms ECoGs can be stored by the RNS Neurostimulator when an ECoG storage trigger occurs The maximum number of ECoGs that can be stored is affected by the number of channel s selected ON for storage and the pre trigger and post trigger durations The oldest stored ECoGs are continually replaced by the newly stored ECoGs except as noted below The number of ECoGs stored for a particular ECoG storage trigger may be reserved Reserved ECoGs are only overwritten by newer ECoGs of the same ECoG storage trigger type ECoG storage may also be scheduled at four different times on a 24 hour clock Selecting ECoG Storage Settings 1 Goto the CONFIGURE SETTINGS tab 2 Select the ECOG STORAGE tab 3 Select the CHANNEL S CH1 through CH4 Only the channels selected ON will be recorded and stored 4 Determine the desired len
84. imulator using the Torque Driver Ensure that the Leads remain completely inserted in the Connector Cover 9 Fully attach the Connector Cover to the RNS Neurostimulator by tightening the screw using the Torque Driver The Torque Driver makes a clicking sound when the screw is completely engaged Note DO NOT use any tools other than the Torque Driver provided to secure the Connector Cover in place RNS System User Manual Surgical Procedures 48 Upper Lead Strain Relief Figure 16 Secure the Connector Cover and Lead s to the RNS Neurostimulator using the Torque Driver 10 Place the upper Lead Strain Relief over the proximal ends of the Leads extending from the Connector Cover Figure 16 and attach it to the post 11 Cover the Programmer Wand with a sterile bag and position it over the Neurostimulator 12 Record the Lead information serial number s and corresponding Neurostimulator port number s on the PATIENT PRODUCT tab of the Programmer Figure 17 RNS Neurostimulator port 1 and 2 locations Port 1 is located towards the center of the Neurostimulator and port 2 is closer to the edge RNS System User Manual Surgical Procedures 49 13 14 15 16 17 18 19 20 Select the desired amplifier sensing channels on the MONTAGE tab under CONFIGURE SETTINGS of the Programmer Program the information into the Neurostimulator View real time ECoG signals on the REAL TIME ECoGs tab
85. ing an Intraoperative Procedure 1 2 3 9 10 11 12 If no ECoG signal is seen make sure Lead labels and montage have been programmed If the signal is too high in amplitude or saturating decrease the gain setting If the Leads are positioned over the RNS Neurostimulator move them away from the Neurostimulator Remove the Connector Cover from the RNS Neurostimulator using the Torque Driver Flush the Connector Cover with Leads inserted and the RNS Neurostimulator connector area with saline Remove the Leads from the Connector Cover Clean the proximal end of the Lead with saline and visually inspect that the Lead end is free of excess blood or other tissue Reinsert the Leads Verify that they are fully inserted into the Connector Cover ports Place the Connector Cover back onto the RNS Neurostimulator Verify once again that the Leads are fully inserted in the Connector Cover ports Secure the Connector Cover onto the RNS Neurostimulator using the Torque Driver View the real time ECoGs to verify that the signal is sufficient and free of noise or artifacts Isolated artifacts may be the result of electrostatic discharge ESD static electricity shocks to the Programmer If the signal contains noise or artifacts disconnect the AC adapter from the Programmer and run on battery power Make sure the battery is charged before doing so Disconnect the network cable as well if it is connected If the
86. is assigned automatically Electrode numbers 1 4 are assigned automatically Distal End of Depth Lead Distal End of Cortical Strip Lead 9 3 9 4 9 Figure 20 For both the Depth Lead and Cortical Strip Lead electrodes are numbered 1 through 4 Electrode 1 is the most distal RNS System User Manual 62 Programming Instructions Recommended Initial Lead Labels e Name the Leads on the PATIENT PRODUCT tab Enter meaningful names for each Lead for example a Lead in the left hippocampus can be labeled LHip Fanen moduei Configure Settings Test Stimulation Neurostimulator Information Patient Information Initials as Gender Female Model RNS 300M 7 0 ROM 2 3 S N 105091 Sw 70 Month Year Day Patient Date of Birth 6 10 1976 Lead Information Lead Label ConnectorPort 1 NP 4 Electrode 7 9 mm2 Depth Lead 10 mm spacing 30 cm length SN1 fi 01678 rip ConnectorPort 2 NP 4 Electrode 7 9 mm2 Depth Lead 10 mm spacing 30 cm length SN2 fi 01789 PHip Additional lead information Emergency Contact Information Note This information is stored in the Neurostimulator Institution Name P Physician Name PO Phone Number 1 FO Phone Number 2 fC O Additional contact information Figure 21 Patient Product tab RNS System User Manual Programming Instructions 63 Creating a Montage 1 Goto the CONFIGURE SETTINGS tab 2 From the MONTAGE screen assign
87. justed to prevent such occurrence Refer to the Interrogation and Testing of the Neurostimulator and Programming the Neurostimulator sections of this manual for instructions on how to perform these tasks RNS System User Manual Troubleshooting 84 TROUBLESHOOTING DAMAGED PRODUCTS Inspect NeuroPace products for any damage or breach in package seal integrity If packaging appears to be wet punctured or damaged contents in package may no longer be sterile Product s with damaged components and or packaging should not be used and should be returned to NeuroPace for replacement GENERAL TROUBLESHOOTING ACTIVITIES Problems with the RNS System may be revealed during an interrogation with the display of an error message on the Programmer or through review of Lead impedances battery measurements or real time ECoGs If attempts to resolve the problem are ineffective and the problem persists complete all of the following activities e Record all error messages displayed e f interrogation of the Neurostimulator is possible complete the interrogation and synchronize the Programmer with the Patient Data Management System e Contact NeuroPace for further assistance Abnormal Lead Impedance greater than 3500 Ohms or less than 250 Ohms Troubleshooting During an Intraoperative Procedure The goal of the following procedures is to ascertain if the abnormal Lead impedance measurement is associated with the Lead or with the R
88. l Mode Option to configure detection using all detection parameters Telemetry Communication between the Neurostimulator and the Programmer Test Stimulation A stimulation that is configured and delivered in real time using a Programmer RNS System User Manual Glossary 106 Therapy limit per day Responsive therapy delivery will be DISABLED for the remainder of the day after the programmed number of responsive therapies has been delivered Therapy sequence Responsive therapy is delivered as a therapy sequence of up to 5 individually configured sequential therapies electrical stimulation in response to each detected episode Tunneling Part of the implant procedure during which the proximal end of an implanted Lead is tunneled from the burr hole location to the Neurostimulator implant location to achieve a Lead Neurostimulator connection Tunneling Tool The cranial Tunneling Tool is intended to tunnel implanted Leads from their point of exit from the cranium through a sub galeal pathway to the implanted Neurostimulator location RNS System User Manual Index 107 INDEX A Abandoning leads 52 About this manual 5 Access Physician amp Center 10 Adaptive pulse interval 104 Adaptive responsive therapy 80 101 Adverse Tissue Reaction 11 Antibiotics 10 33 Area Detector 71 Artifacts 63 84 85 86 87 B Bandpass Detector 72 Battery 27 Longevity 27 Low Measurement 88 Measurement 27 28 56
89. l based on the duration and amplitude of waveform segments Battery Life Optimization Procedure The Programmer delivers brief bursts of the selected therapy in order to determine the optimal Neurostimulator settings for maximizing battery life If this procedure is skipped the Neurostimulator will be programmed with default settings Battery measurement The Neurostimulator battery voltage may be measured interactively through the Programmer Burr hole Hole made in the skull used for the insertion and security of implanted cortical and or depth Leads Burr hole cap The burr hole cap is intended to secure the Leads in relation to the cranium Burr hole cover The burr hole cover is intended to secure the Leads to the burr hole cap Burst An individually programmed group of one to many pulse s of current delivered by the Neurostimulator Burst duration The amount of time during which a burst will be delivered by the Neurostimulator RNS System User Manual Glossary 102 Burst 1 The first burst of stimulation delivered within an individual responsive therapy This burst may be delivered asynchronously or synchronously Burst 2 The second burst of stimulation delivered within an individual responsive therapy This burst may be programmed ON or OFF for each therapy and will always be delivered asynchronously following Burst 1 of the therapy if programmed ON Calculated charge density The charge density of a selected and or prog
90. l be delivered Select the BURST DURATION to determine the length of the stimulation burst Select the PW PER PHASE to determine the duration of each phase of the biphasic current pulse Select the FREQUENCY to determine the frequency of the current pulses the inverse of the duration between the start of one current pulse and the start of a subsequent current pulse Select THERAPY TESTING to test patient toleration of stimulation by delivering test stimulations Stimulation parameters selected on the THERAPY tab are copied to the Therapy Testing Screen Note The RNS System cannot deliver a Test Stimulation while an episode is being detected or during any type of therapy delivery Disable detection and or therapies or wait for a detected episode or therapy delivery to finish in order to continue with a successful Test Stimulation Precaution Afterdischarge Activity If evidence of afterdischarge activity resulting from stimulation is seen either on stored ECoGs or during Test Stimulation delivery stimulation parameters should be adjusted to prevent such occurrence On the Therapy Testing screen select the DELIVER button to initiate a Test Stimulation Delivery of the Test Stimulation may be stopped by selecting the HALT button To store a real time ECoG a select the STOP button to stop the ECoG from scrolling and then b select the STORE button to save the ECoG record RNS System User Manual Programming Instructions
91. le 2 Place the Lead proximal ends into each port of the Connector Cover until the Lead stops 3 Confirm that the Lead marker band is flush with the edge of the Connector Cover If there is a gap between the band and the edge of the Connector Cover seal gently push the Lead into the Connector Cover port again until the Lead stops 4 Confirm that the Lead contacts are fully visible in each window of the Connector Cover Figure 14 Lead contacts should appear in each of the 4 connector cover windows Figure 14 Connector Cover with proximal Lead contacts in place RNS System User Manual Surgical Procedures 47 5 If using only one Lead be sure to place a Connector Plug in the vacant Connector Cover port Connector Plug Figure 15 Neurostimulator Connector Cover with a Connector Plug placed in the one vacant port Precaution Connector Plug A vacant port in the Connector Cover must be filled with a Connector Plug provided in the Connector Cover Kit There is an increased risk of Neurostimulator failure if a Connector Cover port is vacant 6 Remove the white temporary connector cover from the Neurostimulator Note The Neurostimulator connector area is extremely fragile and should be handled with care 7 Flush the Neurostimulator connector area to remove debris and dry area before attaching the Connector Cover 8 Place the Connector Cover on the Neurostimulator and then loosely attach it to the Neurost
92. measurements remain abnormal 24 Close the incision 25 After the incision closure interrogate the Neurostimulator again using the Programmer Confirm that the impedance measurements and real time ECoG signals are normal Note Itis common for the Neurostimulator to reset if electrocautery is used near the Neurostimulator or Leads To recover from a Neurostimulator reset perform the following Document all error messages Proceed with the interrogation Go to the PROGRAM SETTINGS tab and select Program Synchronize the Programmer with PDMS post operatively a A WOW DH gt If problems persist refer to the Troubleshooting section of this manual RNS System User Manual Programming Instructions 55 PROGRAMMING INSTRUCTIONS LOGGING ONTO THE NEUROPACE PROGRAMMER 1 Connect the Wand to the USB port on the Programmer Laptop Connect the AC adapter to the Programmer Laptop and to the power cord Plug the power cord into a grounded power outlet Turn on the Programmer by pressing the power button On d I Access the Programmer graphical user interface GUI by entering NPUser in the USER NAME field and leaving the PASSWORD field blank TESTING THE WAND SIGNAL 1 Goto the Programmer MAIN MENU screen 2 Place the Wand over the Neurostimulator within approximately 3 cm of the device 3 Select the TEsT WAND SIGNAL button The SiGNAL LEVEL S measures the strength of the communication between the Neurostimulator
93. mmended Modifications to ECoG Storage Settings ECoGs stored by the RNS Neurostimulator during the first several days after implantation of the Neurostimulator and Leads may not be representative of the patient s typical baseline activity ECoG storage settings should be reviewed to ensure that the desired activity is being stored If it appears that ECoGs containing the desired activity are being overwritten by later events instruct the patient to use the Remote Monitor and Wand to interrogate the Neurostimulator immediately after each clinical seizure or to interrogate several times per day Several interrogations per day during the first several days after implantation will not have a significant impact on battery life Refer to RNS SYSTEM LONGEVITY for more information e Review ECoGs e ECoGs should be reviewed on the PDMS to determine whether detections and storage are optimal Detectors ECoG List Line Length Detection Features Legend 3 Line Length On Percentage Short Term Trend 4 096 secs Long Term Trend 2mins Boe Feo 7 Note this adjusts the long term line lenath trend for Line Length Threshold RES both patterns on the first detector channel Detection Threshold 75 0 Settings Selection Mode Clinical Navigation Display Options 4 r Simulation Options Timebase Seconds Sensitivity CoG Iv Waveform IV Device Markers Auto Simulate Big IST Wo d5 i
94. mplantation Note The Neurostimulator may be implanted and secured in the craniectomy before or after the tunneling of the Lead s Remove bone debris from the areas inside and surrounding the craniectomy Place the Ferrule in the craniectomy The one pre bent Ferrule tab can be used as a depth guide for placement of the Ferrule Note To properly recess the Ferrule into the skull additional bone removal may be required to accommodate the Ferrule Clamp Bend the three straight Ferrule tabs to the appropriate depth using a needle driver or other surgical instrument Place the Neurostimulator in the Ferrule to assess the fit and position The Neurostimulator Lead exit point should make a smooth transition to the top of the skull when the Neurostimulator is resting in the Ferrule Note The Neurostimulator is packaged with a temporary white cover over the lead contacts Leave this cover in place until you are ready to attach the Leads to protect the contacts during handling Remove the Neurostimulator from the Ferrule Secure the four Ferrule tabs to the skull using bone screws not provided Partially seat the Ferrule Clamp in the Ferrule using the Torque Driver to tighten the Ferrule Clamp screw Do not fully tighten the Ferrule Clamp it should still be able to rotate freely RNS System User Manual Surgical Procedures Ferrule Tabs Figure 11 The four Ferrule tabs secured to the skull with bone screws 8 Fl
95. mulation using a Programmer RNS System User Manual Responsive Neurostimulator System 17 Precaution Precaution Precaution During the procedure e Use of bipolar electrocautery is recommended and should be considered whenever possible e Keep the electrocautery tip more than 2 cm approximately one inch from the implanted device e The selected output power of the electrocautery unit should be as low as possible for the relevant application and not used for greater than 10 seconds in any one burst After the procedure e f stimulation was temporarily disabled before the procedure re enable stimulation with the Programmer and synchronize the Programmer with the PDMS e Advise the patient to contact their healthcare provider as soon as possible if they have questions or suspect their device is not functioning properly after any medical procedure Dental Therapy and Procedures Dental therapy and procedures that do not involve any of the procedures in the Contraindications or Warnings sections of this Manual should be performed with caution The dentist or dental technician should be informed that the patient is implanted with the RNS System Advise the patient to contact their healthcare provider as soon as possible if they have questions or suspect their device is not functioning properly after any medical procedure The following medical procedures may be performed without affecting the RNS System e Diagno
96. ncy Example If the Adaptive 100 and sensed signal frequency 20 Hz 50 ms period the stimulation frequency is delivered at 20 Hz 50 ms p p interval If RNS System User Manual Programming Instructions 81 the Adaptive 50 and the sensed signal frequency 20 Hz 50 ms period the stimulation frequency is delivered at 40 Hz 25 ms p p interval If the Neurostimulator cannot detect a stable frequency in the ECoG signal or if the calculated stimulation frequency is not between the user selected minimum and maximum frequencies MIN FREQUENCY and MAX FREQUENCY then the burst is delivered at the selected default frequency DEFAULT FREQUENCY The following can be configured under the ADVANCED SETTINGS button if a SYNC CHANNEL has been selected on the RESPONSIVE THERAPY main tab Set SYNCHRONIZATION to Synchronous to deliver the first pulse of the burst in response to the ECoG according to the FIRST PULSE DELAY and the SYNCH SLOPE Note Synchronization is only available to be delivered for BURST 1 or PATTERN A in THERAPY 1 and for BURST 1 in THERAPIES 2 5 Note If first pulse synchronization is selected as synchronous but the Neurostimulator is unable to synchronize to a waveform the Neurostimulator reverts to asynchronous therapy delivery after 2 seconds Select RESPONSIVE THERAPY to be ENABLED Select the PROGRAM SETTINGS tab Select REVIEW CHANGES to view changes prior to programming SMO 90 Select the
97. nd run on battery power Make sure the battery is charged before doing so Disconnect the network cable as well if itis connected Move electronic equipment that may be a source of interference or move away from such equipment if possible Turning electronic equipment on and off may help identify the source of any interference e Reposition the Wand over the Neurostimulator and interrogate e View the real time ECoGs to verify that the signal is sufficient and void of noise or artifacts Move the wand to any other available USB port on the Programmer and retry Reboot turn OFF and back ON the Programmer Attempt the interrogation again Try a different Programmer if available Try interrogating a different Neurostimulator if available to see if the problem is with the Neurostimulator Programmer Turns OFF or Freezes AN N Plug Programmer into a grounded power outlet Hold the Programmer Power button down for 5 10 seconds Release the Programmer Power button Press the Programmer Power button again If the Programmer does not restart follow the above instructions again If the Programmer still does not respond contact NeuroPace for further assistance RNS System User Manual Troubleshooting 88 Low Battery Measurement 1 Repeatthe battery measurement 2 lfinterrogation of the RNS Neurostimulator is possible complete the interrogation and synchronize the Programmer with the Patient Data Management System 3
98. nd there are no undesired changes in the ECoG such as afterdischarges Instructions for modifying responsive therapy settings are provided in the section titled Setting up Responsive Therapy RNS System User Manual Surgical Procedures 33 SURGICAL PROCEDURES Implanting physicians should have adequate experience in the implantation of subdural and stereotactic implantation of intraparenchymal electrodes in the surgical treatment of intractable epilepsy have completed the NeuroPace RNS System Training Program and be thoroughly familiar with all product labeling PRE IMPLANT Patient and Family Information The potential risks and benefits of implanting the RNS System and responsive electrical stimulation therapy should be discussed with the patient legal guardians and family members before the implant procedure and during follow up The patient should be counseled that diathermy procedures Magnetic Resonance Imaging MRI procedures ElectroConvulsive Therapy ECT and Transcranial Magnetic Stimulation TMS are contraindicated even if the Neurostimulator is turned off or has been removed or if any Leads or any part of a Lead emain The patient should also be counseled on other medical procedures to avoid and on RNS System care and environmental hazards The RNS System Patient Manual outlines this information and should be provided to and reviewed with the patient prior to the RNS System implant Pre surgical Antibiot
99. new Connector Cover with the windows visible Place the Lead proximal end into each port of the new Connector Cover until the Leads stop Confirm that the Lead marker band is flush with the edge of the connector cover If there is a gap between the band and the edge of the Connector Cover seal gently push the Lead into the Connector Cover port again until the Lead stops Confirm that the Lead contacts are fully visible in each window of the Connector Cover Figure 14 Place the Connector Cover on the Neurostimulator and then loosely attach it to the Neurostimulator using the Torque Driver Ensure that the Leads remain completely inserted in the Connector Cover RNS System User Manual Surgical Procedures 51 21 22 23 24 25 26 2T 28 29 30 31 Note DO NOT use any tools other than the Torque Driver provided to secure the Connector Cover in place Fully attach the Connector Cover to the Neurostimulator by screwing the cover in until the Torque Driver clicks Place the Lead Strain Relief over the proximal ends of the Leads extending from the Connector Cover If using only one Lead be sure to place a Connector Plug in the vacant Connector Cover port Use the Lead Caps provided to cap the proximal ends of any unconnected leads Secure the Lead Caps with a suture if desired Situate all capped unconnected Leads adjacent to the Neurostimulator to facilitate easy connection to the Neurostimulato
100. ng to the transmitter manufacturer and d is the recommended separation distance in meters m Field strengths from fixed RF transmitters as determined by an electromagnetic site survey should be less than the compliance level in each frequency range Interference may occur in the vicinity of equipment marked with the following symbol f a a At 80 MHz and 800 MHz the higher frequency range applies These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitter an electromagnetic site survey should be considered If the measured field strength in the location in which the RNS System is used exceeds the applicable RF compliance level above the RNS System should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or relocating the RNS System RNS System User Manual Over the frequency range 150kHz to 80MHz field strengths should be less than 3 V m Specifications 97 Table 5 Recommended separation distances between portable and mobile
101. nt 33 Replacing Leads 52 Radiation 13 Replacing RNS System 49 Radio Frequency Identification RFID Interference 12 Real time ECoG See ECoG Real time Recommended Settings 30 31 62 63 65 70 77 Remote Monitor 20 Replacing leads 52 Replacing the RNS System 49 Reports 81 Request rejected message 88 Reset See Neurostimulator Reset Responsive Therapy 31 32 75 105 Resterilization 26 Restrictions Use of RNS System 10 Retrieving ECoGs 57 Reviewing Reports 81 RNS System Components amp Accessories 22 Description 19 External Products 19 Handling products 26 Implantable Component Specifications 92 Implantable Products 19 Implanted Figure 19 Neurostimulator See Neurostimulator Use by date 26 RNS System Failure 11 S Security and Electronic Tracking Systems 13 Specifications 90 Stereotactic surgery 37 Sterile packaging 26 34 Sterilization 26 Stimulation disabling 76 Stop gauge 105 Stop Gauge 24 Storage 26 Stylet 105 Surgical Procedure Side Effects 11 Surgical Procedures Abandoning Leads 52 Cortical Strip Lead Implant 30 40 Cranial Prosthesis 51 Craniectomy placement 41 Depth Lead Implant 30 37 Explanting RNS System 49 Implant Flowchart 36 Neurostimlator Leads Connection 45 Neurostimulator Ferrule Implant 41 RNS System User Manual Tunneling 45 46 Suture sleeve 105 Suture Sleeve 24 Symbols Glossary 3 Synchronization 59 T Telemetr
102. nt to or stacked with other equipment If adjacent or stacked use is necessary the Programmer should be observed to verify normal operation in the configuration in which it will be used Emissions and Immunity Information The devices are intended for use in the electromagnetic environment specified below The customer or user of the system should assure they are used in such an environment Table 2 Guidance and manufacturer s declaration electromagnetic emissions for all equipment and systems Emissions test Compliance Electromagnetic environment guidance CISPR 11 Harmonic emissions IEC 61000 3 2 Not Applicable Voltage fluctuations flicker emissions IEC 61000 3 3 Not Applicable RF emissions Group 1 The RNS System uses RF energy only for its internal function Therefore its RF emissions are CISPR 11 very low and are not likely to cause any interference in nearby electronic equipment RF emissions Class B The RNS System is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes RNS System User Manual Specifications 95 Table 3 Guidance and manufacturer s declaration electromagnetic immunity for all equipment and systems Immunity test IEC 60601 test level Compliance level Electrom
103. o two or more antiepileptic medications and currently have frequent and disabling seizures motor partial seizures complex partial seizures and or secondarily generalized seizures The RNS System has demonstrated safety and effectiveness in patients who average 3 or more disabling seizures per month over the three most recent months with no month with fewer than two seizures and has not been evaluated in patients with less frequent seizures CONTRAINDICATIONS The RNS System is contraindicated for e Patients at high risk for surgical complications such as active systemic infection coagulation disorders such as the use of anti thrombotic therapies or platelet count below 50 000 e Patients who have medical devices implanted that deliver electrical energy to the brain e Patients who are unable or do not have the necessary assistance to properly operate the NeuroPace Remote Monitor or Magnet The following medical procedures are contraindicated for patients with an implanted RNS System Energy from these procedures can be sent through the implanted brain stimulation system and cause permanent brain damage which may cause severe injury coma or death Brain damage can occur from any of the listed procedures even if the RNS Neurostimulator is turned off or if the Leads are not connected to the Neurostimulator and can occur even if the Neurostimulator has been removed and any Leads or any part of a Lead or the cranial prosthesi
104. of electromagnetic interference The most common sources of EMI are discussed below Hospital or Medical Environments Patients should always inform healthcare personnel that they have an implanted RNS System and show their Medical Implant Identification Card before any procedure is performed Most diagnostic procedures such as x rays and ultrasounds may be performed without affecting the RNS System However other diagnostic and therapeutic equipment with higher energy levels may interfere with the RNS System Refer to the Warnings and Precautions section for specific information Home Work or Public Environments The patient should avoid or exercise caution when in the presence of the following potential sources of EMI that may affect the operation of the Neurostimulator e Radiofrequency identification RFID sources Power lines and transmission towers Electric substations power generators and large transformers Portable and mobile RF communications equipment Electric arc welding equipment Electric steel furnaces Electric induction heaters Electric fences Body fat measurement scales Jackhammers Stun guns The following commonly used items should not affect the operation of the Neurostimulator e Cell phones and Bluetooth devices e Electric toothbrushes electric shavers and hair trimmers e Microwave ovens e Appliances such as washing machines dryers electric stoves toasters blenders electric can openers and food
105. ol under the scalp until the Tunneling Tool Tip exits near the burr hole Once the tool has exited the burr hole unscrew and remove the tip Slide the Tunneling Tool handle out from the Tunneling Tool Straw leaving the Straw in place Note The Tunneling Tool Straw may be clipped to a shorter length if desired Gently slide the proximal end of the Lead into the Tunneling Tool Straw Advance the Lead from the burr hole to the craniectomy allowing the proximal Lead contacts and Lead body to extend from the craniectomy 10 Remove the Tunneling Tool Straw Note Leave sufficient slack in the Lead adjacent to skull fixation points to relieve stress on the Lead Tunneling with Other Tools 1 2 Using blunt dissection create a channel between the Lead and Neurostimulator positions Pass the lead under the scalp using the Tunneling Tool Straw provided Note The Tunneling Tool Straw may be clipped to a shorter length if desired Gently slide the proximal end of the Lead into the Tunneling Tool Straw RNS System User Manual Surgical Procedures 46 4 Advance the Lead from the burr hole to the craniectomy allowing the proximal Lead contacts and Lead body to extend from the craniectomy 5 Remove the Tunneling Tool Straw Note Leave sufficient slack in the Lead adjacent to skull fixation points to relieve stress on the Lead Securing the Neurostimulator and Lead s 1 Hold the Connector Cover with the windows visib
106. onto the Neurostimulator A Connector Plug must be placed in the Connector Cover if only one Lead is implanted 1 Secure the Neurostimulator in the Ferrule Using the Programmer confirm the integrity of the system Record the Lead serial numbers and Neurostimulator port numbers in the Programmer Close incisions over the burr hole craniotomy and Neurostimulator RNS System User Manual Surgical Procedures 37 RECOMMENDED NEUROPACE DEPTH LEAD IMPLANTATION AND FIXATION Burr Hole Placement 1 Make an incision in the scalp at or near the desired burr hole location 2 Using a standard perforator create a 14 mm burr hole in the skull 3 If using a burr hole cap cover not provided secure the cap base to the skull and follow the manufacturer s Instructions for Use Note Itis necessary to consider the distance from the burr hole to the Neurostimulator implant site when selecting the appropriate Lead length for implantation Depth Lead Insertion The Depth Lead may be implanted using standard stereotactic techniques and planning software The following instructions assume that a stereotactic frame is being used however other stereotactic methods may be used 1 Prepare the stereotactic frame for Depth Lead implantation Lead Holder Guide Tube Insertion Cannula Figure 7 Stereotactic frame assembly example RNS System User Manual Surgical Procedures 38
107. ostimulator delivered therapies Note A full history of stored ECoGs is available on the PDMS Reviewing a List of ECoGs Retrieved From the Neurostimulator for the Current Montage 1 Go to REVIEW DATA tab 2 Select the STORED ECoGs tab Stored ECoGs may also be reviewed under the ARCHIVED DATA tab Precaution Afterdischarge Activity If evidence of afterdischarge activity resulting from stimulation is seen either on stored ECoGs or during Test Stimulation delivery stimulation parameters should be adjusted to prevent such occurrence DELIVERING TEST STIMULATIONS Patient tolerability to stimulation may be verified by delivering Test Stimulations The Test Stimulation function allows the user to configure and deliver two separate Test Stimulations each containing up to two bursts Enabling and Delivering a Test Stimulation 1 Position the Wand over the Neurostimulator 2 Go to TEST STIMULATION tab Setting Up and Delivering Test Stimulation 1 Set the stimulation pathway by selecting at least one electrode as the anode and at least one electrode as the cathode for the stimulation 2 Select the amount of CURRENT that will be delivered 3 Select the BURST DURATION to set the amount of time during which the burst will be delivered 4 Select the PW PER PHASE to set the pulse width i e duration of each phase of the biphasic current pulse 5 Select the FREQUENCY to set the duration between the start of one current
108. p Leads are available in the following lengths 15 centimeters Model CL 315 10 25 centimeters ModelCL 325 10 35 centimeters Model CL 335 10 There are four electrodes spaced 10 millimeters apart from each other All four electrodes can be configured for sensing detection and stimulation WARNING COMPATIBILITY WITH SIMILAR IMPLANTABLE PRODUCTS The NeuroPace RNS Neurostimulator NeuroPace Cortical Strip Lead and NeuroPace Depth Lead are not compatible with non NeuroPace leads and or pulse generators Incompatible configurations may cause damage to the products and may result in unsafe current densities delivered to the patient NEUROPACE DEPTH LEAD The NeuroPace Depth Lead is intended for implant into the brain to provide an interface through which electrical activity of the brain can be monitored and electrical stimulation can be delivered Depth Leads NeuroPace Depth Leads are available in the following configurations 30 centimeter length 10 millimeter electrode spacing Model DL 330 10 30 centimeter length 3 5 millimeter electrode spacing Model DL 330 3 5 44 centimeter length 10 millimeter electrode spacing Model DL 344 10 RNS System User Manual Responsive Neurostimulator System 24 44 centimeter length 3 5 millimeter electrode spacing Model DL 344 3 5 All four electrodes can be configured for sensing detection and stimulation WARNING COMPATIBILITY WITH SIMILAR IMPLANTABLE PRODUCTS
109. packaged Neurostimulator by the Programmer activates the Neurostimulator gt rostimulator 1 Neurostimulator Neurostimulator Neu on um Neurostimulator gt a transitions to shipped inactive functional life active inactive SSS ae an 1897 t Neurostimulator es i Te i T rota battery depletion m ecommender start of life E oe pone replacement of Neurostimulator resets End of service EOS Neurostimulator Note Time axis is not to scale Figure 5 The sequence of RNS Neurostimulator battery life events PRODUCT REGISTRATION Registration of implanted medical products is required by U S federal regulations A registration form is provided with the RNS Neurostimulator and Leads Complete the registration information as soon as possible and return it to NeuroPace RNS System User Manual Clinical Use of the RNS System 29 CLINICAL USE OF THE RNS SYSTEM IDENTIFYING CANDIDATES FOR THE RNS SYSTEM THERAPY Clinical trials have shown that the RNS System is safe and effective in patients who are 18 years of age or older with disabling partial onset seizures from no more than two foci and have medically intractable epilepsy defined by the International League Against Epilepsy ILAE as a failure to control seizures after 2 seizure medications that have been appropriately chosen and used Patients benefiting from the RNS System have partial onset epilepsy with one or more of the following seizure types e Sim
110. ple partial motor seizures characterized by alteration in motor function without change in awareness e Complex partial seizure includes impairment in awareness e Generalized tonic clonic or tonic clonic seizures The RNS System is appropriate only in patients whose seizures begin in one or two foci that can be implanted with NeuroPace Depth and or NeuroPace Cortical Strip Leads Only 2 Leads can be connected to the Neurostimulator and therefore detection and stimulation can occur in no more than 2 locations The RNS System should not be considered in patients who are likely to require N MRIs of the brain in the future because an MRI is contraindicated in patients implanted with the RNS System The RNS System is also contraindicated in patients who have implanted medical devices that deliver electrical energy to the head Patients who have medical or neurological conditions that place them at high risk for surgical complications are not good candidates for the RNS System For a complete list see the Contraindications section LOCALIZING THE SEIZURE FOCUS AND PLANNING LEAD LOCATION The RNS System delivers responsive stimulation to one or two seizure foci In order to accomplish this a precise detection of the electrocorticographic activity of interest must be achieved to provide stimulation to the seizure focus If electrocortiocographic activity of interest is not detected as intended and or stimulation cannot be delivered to th
111. provide guidelines for implanting the RNS System including the NeuroPace RNS Neurostimulator NeuroPace Cortical Strip Leads and NeuroPace Depth Leads and instructions for using the NeuroPace Programmer Manual Contents e Introduction Overview of the typographical conventions and contents of the manual e RNS System Description Indications contraindications product descriptions theory of system operation warnings and precautions e Clinical Use of the RNS System Physician and center access identifying candidates pre surgical planning patient training overview of implantation and initial programming recommendations e Surgical Procedures Instructions for implanting the RNS System Instructions for Use Description of the settings available in the Neurostimulator and instructions for programming instructions for individualizing patient detection settings instructions for individualizing patient therapy settings e Patient Follow Up Guidelines for follow up appointments follow up activities and patient counseling e Troubleshooting Information that may be helpful in solving problems encountered while implanting or operating the RNS System e Specifications List of each product with its mechanical and electrical characteristics e Glossary Alphabetical list of terms used in the manual with their definitions RNS System User Manual Introduction 6 Typographic Conventions This manual uses differen
112. pulse and the start of the subsequent current pulse Frequency is the inverse of duration Note The Neurostimulator cannot deliver a Test Stimulation while an episode is being detected or during any type of therapy delivery Disable detection and or therapies or wait for a detected episode or therapy delivery to finish in order to continue with a successful Test Stimulation Precaution Afterdischarge Activity If evidence of afterdischarge activity resulting from stimulation is seen either on stored ECoGs or during Test Stimulation delivery stimulation parameters should be adjusted to prevent such occurrence RNS System User Manual Programming Instructions 59 PW Phase Current qc Frequency Burst Duration total Figure 18 The parameters of a single burst of stimulation 6 Select the DELIVER button to initiate the Test Stimulation Delivery of the Test Stimulation may be stopped by selecting the HALT button Storing a Real time ECoG 1 Select the STOP button to stop the ECoG from scrolling 2 Select the STORE button to save the ECoG record Note The length of the ECoG stored equals the buffer size up to a maximum of 4 minutes SYNCHRONIZING THE PROGRAMMER WITH THE NEUROPAcE PATIENT DATA MANAGEMENT SYSTEM The Programmer should be synchronized with the NeuroPace Patient Data Management System PDMS upon Neurostimulator re programming or collection of new Neurostim
113. r hole Precaution Sub galeal Lead Placement Wrapping the Lead s on around the Neurostimulator or placing excess Lead near the Neurostimulator may result in Lead damage during subsequent surgical procedures RECOMMENDED NEUROPAcE CORTICAL STRIP LEAD IMPLANTATION AND FIXATION Cortical Strip Lead Insertion Note 1 2 The Cortical Strip Lead may be implanted in a manner similar to standard strip lead implants Make an incision in the scalp at or near the craniectomy location Perform a craniectomy to insert the strip lead Separate and dissect the dura around the area of desired Cortical Strip Lead implant Precaution Epidural Lead Placement Leads placed epidurally may cause pain during electrical stimulation Retract or remove the stylet by pinching the stylet retainer gently pulling the stylet away from the Lead body and then withdrawing the stylet from the Lead body the desired distance Carefully advance the Cortical Strip Lead to the desired location Verify that the Lead is in the desired anatomical position Cortical Strip Lead Stabilization 1 Fully remove the stylet Note DO NOT reinsert the stylet into the Lead after it has been removed Leave approximately 10 mm of the Lead inside the craniectomy to allow slack before securing the Lead to the skull Cortical Strip Leads can be stabilized using the Suture Sleeves provided in the lead kit Place the Suture Sleeve on the lead body at the poin
114. r in the future Place any excess lead length in a sub galeal pocket near the craniectomy away from the incision line Note Leave sufficient slack in the Lead adjacent to skull fixation points to relieve stress on the Lead Cover the Programmer Wand with a sterile bag and position it over the Neurostimulator Program the new Neurostimulator with the same settings as the explanted Neurostimulator View real time ECoG signals on the REAL TIME ECoGs tab under REVIEW DATA tab and measure Lead impedance s under MEASUREMENTS tab to ensure proper connection between the Neurostimulator and the Leads If impedance measurements are abnormal or real time ECoG signals are not adequate remove the Connector Cover and flush the connector area Fully reinsert the leads into the Connector Cover and repeat the impedance measurements Refer to Troubleshooting section if impedance measurements remain abnormal Close the incision After the incision closure interrogate the Neurostimulator again using the Programmer Confirm that the impedance measurements and real time ECoG signals are normal Note Itis common for the Neurostimulator to reset if electrocautery is used near the Neurostimulator or Leads To recover from a Neurostimulator reset perform the following Document all error messages Proceed with the interrogation Go to the PROGRAM SETTINGS tab and select Program Synchronize the Programmer with PDMS post operatively QA KR NH g
115. rage these are called ECoG Triggers There are three recommended ECoG Triggers to be programmed at implant The first is a Magnet swipe by the patient which could indicate that a clinical seizure has occurred The others are Saturation high amplitude ECoG and Long Episode sustained changes in the ECoG both of which could indicate an electrographic seizure Instructions for setting up the initial detection and ECoG storage parameters are provided in the sections titled Setting up Detection and Setting up ECoG Storage After implantation the patient should be instructed to interrogate their Neurostimulator daily using the Remote Monitor and to transfer that data to the PDMS at least weekly so that sufficient data are stored for the physician s review The patient should be seen approximately 2 weeks after implant so that the physician can review the detections using the stored ECoGs Recommended Initial Responsive Therapy Settings Responsive stimulation therapy should be enabled once the physician has determined the electrographic activity of interest is being detected Recommended initial responsive therapy settings are a frequency of 200 Hz pulse width of 160 usec and burst duration of 100 ms Current amplitude should be initially programmed at 1 0 mA In general stimulation should be delivered to the leads and electrodes from which electrographic patterns of interest are observed For example if electrographic activity of interest i
116. rammed stimulation is calculated by the Programmer Charge densities greater than 25 uC cm phase are not allowed to be selected or programmed into the Neurostimulator Can Can is used to describe the Neurostimulator titanium body The can may be used as either an anode or cathode in a stimulation pathway Cathode The negative pole of an electrode selected for stimulation Configure detection Analysis of detection settings using the Programmer detection tools and retrieved Neurostimulator ECoG records Connector Cover The Connector Cover is intended to secure the proximal Lead contacts and Lead Strain Relief to the body of the Neurostimulator Connector Cover Port The Connector Cover ports contain the point of contact between the proximal end of the Lead s and the Neurostimulator The Connector Cover contains two 2 ports one for each Lead Connector Plug The Connector Plugs are used to fill any ports on the connector head of the Neurostimulator that are not in use Cortical Strip Lead The Cortical Strip Lead is intended for subdural implant to provide an interface through which electrical activity of the brain can be monitored and electrical stimulation may be delivered Craniectomy Defect formed in the skull in order to implant the Neurostimulator Cranial Prosthesis The Cranial Prosthesis is intended to occupy the vacant craniectomy after the Neurostimulator has been explanted Craniectomy Template The Cran
117. ranial hemorrhage may occur when implanting the RNS System Placing the Leads Ferrule and or Neurostimulator in an area where excess pressure may occur to the underlying blood vessels may cause intracranial hemorrhage Patients with underlying risk factors for intracranial hemorrhage such as patients with previous head trauma anticoagulant use or who experience head injury with seizures should be taken into specific consideration WARNING SURGICAL PROCEDURE SIDE EFFECTS Surgical procedure risks may include but are not limited to temporary pain at the implant site CSF leakage and although rare epidural hemorrhage seroma subdural or epidural hematoma and paralysis WARNINGS RNS SYSTEM AND THERAPY WARNING ADVERSE TISSUE REACTION Allergic reaction to the RNS System materials and or Leads implanted is possible WARNING CHRONIC TISSUE STIMULATION The effects of long term brain stimulation are not completely known and may present some risks to the patient WARNING EROSION Skin erosion may occur on and or around the Neurostimulator and or Lead implant site particularly in the case of protrusion of the implanted RNS System products above the surface of the skull WARNING LEAD MIGRATION The implanted Lead s may migrate from their desired implant location Lead migration can result in changes in detections and stimulation effectiveness and may require additional surgical procedures to modify the Lead location WARNING
118. red in response to any event detector as depicted in Figure 35 All subsequent therapies deliver a maximum of 2 bursts and are independent of the event detector Therapy 1 Pattern A Pattern A Detected 7 PattemB I I p 7 Detected Note Time durations not to scale eM wer Therapy 2 Therapy 2 Therapy 3 Therapy 3 Therapy 1 Burst 1 Burst 2 Burst 1 Burst 2 Pattern B Episode Start Redetect Redetect Figure 34 A THERAPY SEQUENCE DELIVERED IN RESPONSE TO A SPECIFIC EVENT DETECTOR Therapy 1 is configured to deliver a single burst in response to a specific detector In this example Pattern A is detected at the episode start Therapy Pattern A burst is delivered If Pattern B is detected at the episode start Therapy Pattern B burst is delivered Subsequent therapies Therapy 2 and Therapy 3 are configured to deliver 2 bursts each no matter which Pattern is subsequently detected Note Time durations not to scale Arr Therapy 1 Therapy 1 Therapy 2 Therapy 3 Therapy 3 Burst 1 Burst 2 Burst 1 Burst 1 Burst 2 Episode Start for Pattern A or Pattern B Redetect Redetect Figure 35 A THERAPY SEQUENCE DELIVERED IN RESPONSE TO ANY EVENT DETECTOR Therapy 1 is configured to deliver Burst 1 and Burst 2 in response to any event detector In subsequent therapies Therapy 2 is configured to deliver Burst 1 only and Therapy 3 is configured to deliver Burst 1 and Burst 2 RNS System User Manual Programming Instructions 6
119. rgency Contact Information 60 Handling 26 RNS System User Manual Impedance Measurement See Impedance measurement Implantation 30 41 Inactive mode 28 Initial Settings 30 31 62 63 65 70 77 Interrogation See Interrogation Longevity 27 Modifying Settings 32 67 70 80 Obtaining Activity Information 57 Patient Information 60 Programming 30 31 32 55 60 64 Recommended Settings 30 31 62 63 65 70 77 Recording ECoGs 30 56 64 65 Reset 28 49 51 54 88 105 Responsive Therapy 31 32 75 Reviewing ECoG Records 57 Securing Connector Cover 46 Specifications 90 91 Noise 18 55 86 104 P Pacemaker 17 Patient Data Collection 12 Patient Data Management System PDMS 19 25 27 59 104 Patient Follow Up 83 Patient Information 60 Patient training 30 PC Stimulation See Test Stimulation PDMS 19 25 Planning Lead Location 29 Planning Surgical 29 Post episode interval 76 104 Potential Shock 13 Precautions Home or Occupational 18 Medical Environment 16 Programmer 16 RNS System and Therapy 15 Surgical 15 Pregnant Women 11 Product Compatibility 10 Product handling 26 Product registration 28 Product storage 26 Programmer 19 104 Components and Accessories 25 Description 24 Failure 87 Logging in 55 Pre implant preparation 33 Specifications 92 Synchronizing with PDMS 59 Programming 104 Q Qualification Physician amp Center 10 Index 109 R Pre Impla
120. rience and certification requirements for neurologists at Comprehensive Epilepsy Centers but who are not practicing in such centers This situation might occur if the patient is not able to travel to a Comprehensive Epilepsy Center for regular follow up e g because of distance from the Center or limited access to transportation These neurologists will be qualified by NeuroPace to provide post implant programming After NeuroPace RNS System training is complete the qualified programming neurologist may receive external NeuroPace products Programmer Remote Monitor WARNINGS SURGICAL WARNING WARNING WARNING COMPATIBILITY WITH SIMILAR IMPLANTABLE PRODUCTS The NeuroPace RNS Neurostimulator NeuroPace Cortical Strip Lead and NeuroPace Depth Lead are not compatible with non NeuroPace leads and or pulse generators Incompatible configurations may cause damage to the products and may result in unsafe current densities delivered to the patient CORTICAL STRIP LEAD EXPLANTATION Explanting a chronically implanted Cortical Strip Lead may cause tissue damage INFECTION Infection including bacterial meningitis may occur as a result of the RNS System implant procedures and or the RNS System materials Standard surgical infection prevention measures antibiotics etc should be taken both pre and post implantation RNS System User Manual Responsive Neurostimulator System 11 WARNING INTRACRANIAL HEMORRHAGE Intrac
121. s observed on all channels then the stimulation pathway should be configured to stimulate across all electrodes However if electrographic activity of interest is observed on only 2 channels then the stimulation pathway should be configured such that current is delivered through only those electrodes with electrographic activity of interest Recommended Initial Responsive Therapy Settings Frequency 200 Hz Pulse Width 160 us Burst Duration 100 ms Current 1 0 mA and adjusted as necessary Electrodes Those from which patterns of interest are observed Stimulation should be tested while the patient is in the physician s office by using the Therapy Testing function This ensures that the patient tolerates the stimulation settings and that there are no undesired changes in the ECoG If the patient cannot tolerate the stimulation settings or there are changes of concern in the ECoG the current amplitude should be reduced Instructions for setting up the initial stimulation parameters are provided in the section titled Setting up Responsive Therapy RNS System User Manual Clinical Use of the RNS System 32 Modifying Detection and Responsive Therapy Settings Once the Neurostimulator is programmed to provide responsive stimulation the patient should be seen at approximately 3 month intervals to determine whether detection and or responsive therapy settings should be modified At each patient visit the physician revi
122. s remain e MR imaging is contraindicated for patients with an implanted RNS System Do not perform an MRI on a patient with any implanted RNS Neurostimulator or Lead or any portion of a Lead Even if the Neurostimulator has been removed you should not have an MRI if any part of a Lead or the Cranial Prosthesis is still implanted The RNS System is MR Unsafe Testing has not been performed to define conditions of use to ensure safety of the RNS System in an MR environment e Diathermy procedures are contraindicated in patients implanted with an RNS Neurostimulator and associated Leads Diathermy is any treatment that uses high frequency electromagnetic radiation electric currents or ultrasonic waves to produce heat in body tissues Patients absolutely CANNOT be treated with any type of shortwave microwave or therapeutic ultrasound diathermy device whether or not it is used to produce heat These treatments should not be applied anywhere on the body e Electroconvulsive Therapy ECT is contraindicated for patients with an implanted RNS System e Transcranial Magnetic Stimulation TMS is contraindicated for patients with an implanted RNS System RNS System User Manual Responsive Neurostimulator System 10 WARNINGS AND PRECAUTIONS WARNINGS CLINICAL USE WARNING WARNING PHYSICIAN AND CENTER ACCESS TO THE RNS SYSTEM The RNS System should only be implanted by neurosurgeons with adequate experience in th
123. s the device to redetect more quickly e Gradual and systematic adjustments to detection will result in more predictable changes in the detection rate RNS System User Manual 73 Programming Instructions Line Length Detection Features Legend Line Length On Percentage Short Term Trend 4 096 secs Long Term Trend 2 mins Urs Note this adjusts the long term line length trend for Line Length Threshold SS both patterns on the first detector channel Detection Threshold 75 0 Settings Selection Mode Clinical Display Options Simulation Options IV Wavefom V Device Markers Auto Simulate Spectrogram J Minor Grid Detection Features Navigation Timebase Seconds Sensitivity Pirersrwris Mix 2x LL 30 60 W En eECoG 4x 8 Does DURS WEEE First Detector Second Detector Figure 32 Line Length tab e Configure BANDPASS detector s Figure 33 Bandpass detectors can improve detection response time because they use shorter detection windows and do not rely on a long term trend Bandpass is very specific to a band of frequencies and an amplitude as programmed by the physician e After several ECoGs with activity have been stored a Bandpass detector should be considered if the activity has a stereotypical frequency RNS System User Manual 74 Programming Instructions Configure Settings Patten 10 32 Hz Sinusoid Minimum Amplitude of Full Scale eat Number of Qualifie
124. sponsive stimulation to one or two epileptic foci Up to five individually configured sequential stimulations can be delivered when a specific ECoG pattern is detected Each stimulation can contain two bursts that can be independently configured The RNS Neurostimulator can store segments of electrocorticographic activity electrocorticograms ECoGs Neurostimulator status indicators and records of events including detection and therapies detected by the Neurostimulator The Neurostimulator can store up to a maximum of 30 minutes of ECoG activity segments A Test Stimulation function allows the user to test the current output of the Neurostimulator and its effect on the patient WARNING COMPATIBILITY WITH SIMILAR IMPLANTABLE PRODUCTS The NeuroPace RNS Neurostimulator NeuroPace Cortical Strip Lead and NeuroPace Depth Lead are not compatible with non NeuroPace leads and or pulse generators Incompatible configurations may cause damage to the products and may result in unsafe current densities delivered to the patient RNS SYSTEM COMPONENTS AND ACCESSORIES Cranial Prosthesis Model P 01 The Cranial Prosthesis occupies a vacant Ferrule if the Neurostimulator has been explanted and not replaced Craniectomy Template Model CT 01 The Craniectomy Template may be used as a pattern to mark and delineate the shape of the Ferrule on the skull prior to making a craniectomy Connector Cover Model CC 01 The Connector Cover sec
125. stic x rays e Diagnostic ultrasound Other Active Implanted Medical Devices RNS System interactions with other active implantable medical devices such as pacemakers defibrillators implanted spinal cord and peripheral nerve stimulators cochlear implants and vagus nerve stimulators are not known Exercise caution when other implanted devices are operating concurrently with the RNS System Possible effects include sensing problems and inappropriate device responses Incompatibility of NeuroPace Programmer with Other Medical Devices The effects of using the NeuroPace Programmer to interrogate other electronic programmable devices such as pacemakers defibrillators cochlear implants and other neurostimulators or CPAP machines are unknown It could result in reprogramming of the other device and therefore the physicians familiar with each device should check the programmed parameters of each device before the patient is discharged and after each programming session of either device RNS System User Manual Responsive Neurostimulator System 18 Precaution Precaution Precaution Electronic Interference Communications between the Programmer and the implanted Neurostimulator may be interrupted by emissions from nearby electronic devices Examples of sources of EMI are lithotripsy computer monitors cellular telephones motorized wheel chairs x ray equipment and other monitoring equipment Interruption of telemetry can r
126. stimulator is a responsive Neurostimulator and does not have High Medium and Low operating settings Calculated Battery Longevity to End of Service EOS Model RNS 300M Patient Use Profile v Pe i SEEN Low 5 Percentile 705 4 26 Medium 50 Percentile 705 3 91 High 95 Percentile 705 2 64 Estimated battery longevity following 9 months of shelf storage These patient use profiles were derived from data collected during the RNS System Clinical Investigations in Epilepsy through May 12 2011 The data battery use in mAh day at the 5th 50th and 95th percentile levels were used to calculate the battery longevity estimates presented in the table above These same data have been converted into the profiles in the table below to illustrate typical therapy parameters that would Lead to the specified battery use Note that e g half as many bursts per day with twice the burst duration would provide identical battery life Patient Use Profiles Parameter Unit th LOW Medium th High i 5 Percentile 50 Percentile 95 Percentile Current mA 6 6 12 Frequency Hz 200 200 200 Pulse Width usec 160 160 200 Burst Duration msec 100 100 100 Bursts per day 100 570 1330 RNS System User Manual Responsive Neurostimulator System 28 Elective Replacement Indication ERI The Programmer reports the Neurostimulator battery voltage each time it is interrogated The el
127. t If problems persist refer to the Troubleshooting section of this manual Replacing the RNS Neurostimulator with a Cranial Prosthesis di 2 3 Using the Programmer disable detection and therapy Verify the position of the Leads to avoid damaging the Leads during incision Make an incision in the scalp at the Neurostimulator location RNS System User Manual Surgical Procedures 52 10 11 12 13 14 Note Itis not necessary to explant the implanted Ferrule when replacing the Neurostimulator with a Cranial Prosthesis however the Ferrule Clamp may be replaced Clear tissue and bone debris away from the area surrounding the Neurostimulator and Lead Strain Relief implant area Remove the Lead Strain Relief top from the Neurostimulator Use the Torque Driver to loosen and remove the Connector Cover Using the Torque Driver partially loosen the screw in the Ferrule Clamp and swivel 90 degrees away from the Neurostimulator to facilitate removal of the Neurostimulator Remove the Neurostimulator from the Ferrule Note Return the explanted Neurostimulator and Leads to NeuroPace NeuroPace will provide shipping containers if requested Remove the proximal Lead ends from the Connector Cover Precaution Lead Damage Bending kinking and stretching of the Lead may cause Lead damage Handle the Lead with care Flush the craniectomy and Ferrule Place the Cranial Prosthesis in the Ferrule Secure t
128. t formats and symbols to distinguish instructions warnings precautions notes lists and figures WARNING WARNING TITLE Warnings alert the user to serious adverse events and potential safety hazards and situations that may cause injury Precaution PRECAUTION TITLE Precautions alert the user to exercise special care in the safe and effective use of the RNS System Note Notes provide additional information that is particularly useful or important 1 Numbered paragraphs contain instructions that provide explanations and or procedural information e Bullet points indicate items in a list Figure Statements regarding a figure are located below the figure between double lines such as this Bold italicized text refers the user to a specific location in this manual for further details BOLD SMALL CAPS assist the user in navigating to the appropriate tab or button on the NeuroPace Programmer screen RNS System User Manual Introduction The tabs are displayed on the NeuroPace Programmer screen as follows RNS System User Manual Page Button Introduction RNS System User Manual Responsive Neurostimulator System 9 RNS SvsTEM INDICATIONS The RNS System is an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci are refractory t
129. t where stabilization is desired Then use non absorbable sutures to ligate the Suture Sleeve to the adjacent tissue to stabilize the lead Precaution Suture Sleeves Suture Sleeves are provided for use if sutures are used to stabilize the Lead Suturing directly on the Lead may cause Lead body damage and malfunction Place Lead Caps provided on the proximal end of unconnected Leads Note If implanting two Leads that will not be connected apply a non absorbable suture tie to one Lead Cap to distinguish the unconnected leads Record the anatomical position of the unconnected leads noting which lead has the non absorbable suture marker RNS System User Manual 41 Surgical Procedures Precaution Sub galeal Lead Placement Wrapping the Lead s on around the Neurostimulator or placing excess Lead near the Neurostimulator may result in Lead damage during subsequent surgical procedures RECOMMENDED RNS NEUROSTIMULATOR IMPLANTATION PROCEDURE Craniectomy Placement The recommended location of the Neurostimulator is in the parietal skull However the Neurostimulator may be implanted anywhere in the skull in a position that achieves a good contoured fit and allows the Neurostimulator to sit flush with the cranial surface The Neurostimulator can be inserted into the Ferrule in only one orientation and the Leads exit the Connector Cover from only one direction Review the Neurostimulator orientation and Lead exit point prior
130. tion system may interact with the sensing operation from a cardiac device and could result in an inappropriate response of the cardiac device and vice versa WARNINGS PROGRAMMER WARNING POTENTIAL SHOCK Submerging any part of the Programmer or operating the Programmer in or near a wet environment may result in an electrical shock The Programmer must be disconnected from the electrical outlet prior to cleaning to avoid the potential of electrical shock Electrical shock may occur if the Programmer AC adapter and power cord are not properly connected to a grounded power source WARNINGS MEDICAL ENVIRONMENT WARNING WARNING LITHOTRIPSY The effects of Extracoporeal Shock Wave Lithotripsy on the RNS System have not been studied Exposure to high output ultrasonic frequencies may damage the RNS System This could result in loss of therapy and additional surgery to remove or replace components of the RNS System Prior to any administration of lithotripsy the administering physician should consult with the physician prescribing the RNS System RADIATION The effects of high radiation sources such as cobalt 60 or gamma radiation used in cancer therapy on the RNS System have not been studied Exposure to high levels of radiation may damage the RNS System This could result in loss of therapy and additional surgery to remove or replace components of the RNS System Prior to any course of radiation therapy the r
131. tor and Wand as well as how to use the Magnet to mark clinical seizures e After implantation provide the patient with the Medical Implant Identification Card e Instruct the patient and or caregiver to interrogate the Neurostimulator every day using the Remote Monitor and Wand and to synchronize the Remote Monitor with the PDMS at least once a week preferably every day OVERVIEW OF IMPLANTATION AND PROGRAMMING OF THE RNS SYSTEM Implanting the RNS Neurostimulator and Leads The RNS Neurostimulator is cranially implanted A ferrule is secured to a full thickness craniectomy and then the Neurostimulator is placed within the ferrule The recommended location of the Neurostimulator is in the parietal skull but this can be modified based on the location of the Leads and the curvature of the patient s skull The Neurostimulator may be implanted and secured in the ferrule before or after the Leads are implanted Instructions for implanting the RNS Neurostimulator are provided in the Surgical Procedures section Leads are placed using standard neurosurgical techniques NeuroPace Depth Leads may be implanted using standard stereotactic techniques through a burr hole in the skull then secured by a burr hole cover such as the NeuroPace Burr Hole Cover Model 8110 NeuroPace Cortical Strip Leads are implanted through a craniectomy in a manner similar to standard strip lead placements then secured using suture sleeves Leads are tunneled under th
132. triggers initiate ECoG storage when the amplitude of the ECoG is high Selecting this trigger may be helpful in troubleshooting the RNS System This trigger can be used whenever detection is ENABLED MAGNET triggers initiate ECoG storage when a Magnet is passed by or placed over the RNS Neurostimulator Selecting this trigger may be helpful in storing electrographic events that correspond to clinical symptoms experienced by the patient e SCHEDULED triggers initiate ECoG storage at a specific time of day ECOG STORAGE START TIMES Selecting this trigger may be helpful in viewing activity occurring during specific times throughout the day This trigger can be used whenever scheduled ECoGs are ENABLED 6 Enter the number of ECoGs that will be reserved for each ECoG storage trigger Recommended Initial ECoG Storage Settings Program settings to capture electrocorticograms on the ECOG STORAGE tab as follows e SELECT CHANNELS FOR ECOG STORAGE all four channels ON e SELECT LENGTH OF STORED ECOG Choose PRE 60 sec Posr 30 sec 90 e SELECT EVENTS TO TRIGGER ECOG STORAGE e LONG EPISODE Triggers ON Reservations 2 Length 30 SECS e MAGNET Triggers ON Reservations 2 e Saturation Triggers ON Reservations 0 e Set all other event Triggers to OFF RNS System User Manual Programming Instructions 66 dd ddd E i Figure 24 ECoG Storage tab RNS System User Manual Programming Instructions 67 Reco
133. tudies following the surgery to adequately localize the seizure focus or foci prior to implantation of the NeuroPace System RNS System User Manual Clinical Use of the RNS System 30 The Leads to be implanted are selected based on the location of the seizure focus NeuroPace Cortical Strip Leads are recommended for seizure onsets on the surface of the cortex where the Cortical Strip Leads may be placed over the focus NeuroPace Depth Leads are recommended for seizure onsets beneath the cortical surface such as within the mesial temporal lobe or within subcortical lesions such as dysplasias where the Depth Lead may be placed within the seizure focus Several Lead lengths are available refer to the NeuroPace Cortical Strip Lead section and the NeuroPace Depth Lead section The Lead model selected should be the appropriate length to reach from the seizure focus to the Neurostimulator with as little excess Lead as possible Up to four Leads can be implanted no more than two Depth Leads For example two Depth Leads and two Cortical Strip Leads or one Depth Lead and three Cortical Strip Leads could be implanted Only two Leads can be connected to the Neurostimulator at a given time unconnected Leads should be capped Leads connected to the Neurostimulator can be changed at a subsequent procedure if desired PATIENT TRAINING e Prior to the implant surgery train the patient and or caregiver how to use the NeuroPace Remote Moni
134. ulator data Database synchronization sends a copy of the Neurostimulator interrogation and programming information stored on the Programmer to the PDMS Additional Resources Describing the Patient Data Management System The Patient Data Management System User Manual Synchronizing the Programmer with the PDMS 1 Connect the Programmer to the Internet 2 Go to the Programmer MAIN MENU screen 3 Select the TRANSFER DATA button 4 Select the SYNCHRONIZE button to synchronize with the PDMS This screen also displays Detection Sets received from the PDMS You must ACCEPT these sets before you can program them into the Neurostimulator Note A notification should appear on the Programmer to confirm that synchronization is complete RNS System User Manual Programming Instructions 60 PATIENT INFORMATION AND PHYSICIAN EMERGENCY CONTACT INFORMATION Entering Patient Information into the Programmer 1 Goto the PATIENT PRODUCT tab 2 The user should enter the following information for each patient e PATIENT IDENTIFIER e GENDER and e DATE OF BIRTH Entering Physician Emergency Contact Information Physician emergency contact information may be entered for storage on the Neurostimulator This information may be used by emergency medical personnel or another physician to contact the patient s physician or caregiver 1 Go to PATIENT PRODUCT tab 2 Enter information to be stored in RNS Neurostimulator Programming Inform
135. ures the proximal Lead contacts to the Neurostimulator Connector Plug Model CP 01 The Connector Plugs must be used to fill all vacant ports in the Connector Cover RNS System User Manual Responsive Neurostimulator System 23 Ferrule and Ferrule Clamp Model F 01 and Model FC 01 The Ferrule is installed in a craniectomy to secure and mechanically support the RNS Neurostimulator in the skull The Ferrule Clamp is used to secure the Neurostimulator to the Ferrule Lead Strain Relief Model LSR 01 The Lead Strain Relief supports the proximal end s of the Lead s at their exit from the Neurostimulator Connector Cover protecting the Lead from stress near the connector Magnet Model M 01 The Magnet is a doughnut shaped magnet which when placed over the implanted RNS Neurostimulator suppresses therapy as long as the Magnet is in position and if the Neurostimulator is programmed to do so triggers an electrocorticogram ECoG storage Torque Driver Model TD 01 The Torque Driver is used to tighten the screw that secures the Connector Cover to the Neurostimulator and to tighten the Ferrule Clamp that secures the Neurostimulator to the Ferrule NEUROPACE CORTICAL STRIP LEAD The NeuroPace Cortical Strip Lead is intended for subdural implant to provide an interface through which electrical activity of the brain can be monitored and electrical stimulation can be delivered Cortical Strip Leads NeuroPace Cortical Stri
136. use will suspend the Neurostimulator diagnostic and ECoG storage and real time ECoGs The pause may last from 2 10 seconds Pulse A biphasic waveform of electrical stimulation delivered by the Neurostimulator Pulse count The pulse count is the number of times a pulse will be delivered in a burst This count is calculated and displayed on the Programmer for each selected therapy Pulse interval adaptation The Neurostimulator may be programmed to deliver the pulse interval for a responsive therapy burst by adapting to the electrographic signal by a selected percentage Pulse interval type For responsive therapy bursts the pulse interval type can be selected as adaptive or fixed Pulse to pulse p p interval The duration between the start of one stimulation pulse and the start of a subsequent pulse Pulse width per phase PW Duration of a single phase within a biphasic pulse measured in milliseconds Real time ECoG ECoG data viewed in real time through the Programmer Recovery period Period of time after the end of Noise detection during which the Neurostimulator attempts to determine post episode baseline activity RNS System User Manual Glossary 105 Reset When the Neurostimulator is reset the following will occur Detection and all therapies will be disabled no ECoGs will be stored and no diagnostics will be stored however events prior to reset will be saved If a Neurostimulator reset occurs the user should note
137. ush the craniectomy and Ferrule 9 Place the Neurostimulator in the Ferrule 10 Rotate the Ferrule Clamp so that it engages the Neurostimulator then fully tighten the Ferrule Clamp screw until the Torque Driver clicks Figure 12 Note DO NOT use any tools other than the Torque Driver provided to secure the Ferrule Clamp in place RNS System User Manual Surgical Procedures 44 Figure 12 The Ferrule Clamp securing the Neurostimulator to the Ferrule Precaution Scalp Necrosis Protrusion of the implanted RNS System products above the surface of the skull may cause necrosis of the scalp RNS System User Manual Surgical Procedures 45 CONNECTING THE RNS NEUROSTIMULATOR TO THE IMPLANTED LEAD S Tunneling with the Tunneling Tool 1 Remove the temporary cover from the end of the Tunneling Tool with tip remaining on the opposite end of the cover Slide the Tunneling Tool through the Tunneling Tool Straw Using the temporary cover as an anchor screw the Tunneling Tool Tip to the end of the Tunneling Tool Remove the temporary cover from the Tunneling Tool Tip Note The Tunneling Tool may be bent to the desired angle Using the Tunneling Tool tunnel under the scalp from the Neurostimulator implant site to the Lead burr hole Handle Straw Tool Body Tip Figure 13 The Tunneling Tool is used to tunnel the Lead under the scalp from the burr hole to the craniectomy Advance the Tunneling To
138. v Dx 12x Spectrogram J Minor Grid I Detection Features a Ne ECoG Length Not Available 30 60 v EnieECoG M 4x ox Cursor Posi First Detector Second Detector Figure 25 Line Length tab RNS System User Manual Programming Instructions 68 If ECoG storage needs to be modified adjust the LoNG EPISODE LENGTH the MAGNET trigger and or the LENGTH OF STORED ECoG e The LONG EPISODE LENGTH duration may be adjusted longer or shorter to capture the desired activity e The MAGNET ECOG trigger may be removed if the patient is not able to apply the Magnet before or immediately after a clinical seizure or if the Magnet triggered ECoG is not useful Magnet applications will still be counted and reported in the diagnostics e The LENGTH OF STORED ECOG value may be increased if longer ECoGs are desired and decreased if a larger number of ECoGs are desired Configure Settings Summary Patient Product Review Data Program Settings Test Stimulation ECoG Storage Responsive There Select Channels for ECoG Storage CH1 LHip1 LHip2 CH3 RHip1 RHip2 On CH2 LHip3 LHip4 On CH4 RHip3 RHip4 On Select Length of Stored ECoG Pre 60 sec Post 30 sec 90 Select Events to Trigger ECoG Storage Triggers Reservations Long Episode Length Long Episode on 2 20 secs Magnet Ott way Responsive Therapy Off P Pattern A Detection Off NEEEN Pattern
139. vailable for each responsive therapy burst For an adaptive therapy burst Adaptive Frequency ON the Adaptive Max Frequency specifies the maximum stimulation frequency If the calculated stimulation frequency does not fall between the programmed Min and Max Frequencies then the stimulation is delivered at the Adaptive Default Frequency Adaptive Min Frequency The Adaptive Min Frequency is an advanced setting available for each responsive therapy burst For an adaptive therapy burst Adaptive Frequency ON the Adaptive Min Frequency specifies the minimum stimulation frequency If the calculated stimulation frequency does not fall between the programmed Min and Max Frequencies then the stimulation is delivered at the Adaptive Default Frequency Amplifier gain ECoG signal amplification on one channel of the Neurostimulator Amplifier input Amplifier inputs are the two electrode sensing inputs to process and generate one amplified and filtered ECoG signal in the Neurostimulator Annotation Annotations are placed by the user on a stored ECoG record to mark the type of activity present Anode The positive pole of an electrode selected for stimulation Area detection tool The area detection tool measures the area under the curve of an ECoG signal Asynchronous pulse Delivery of the first pulse in a burst independent of the ECoG activity Bandpass detection tool The bandpass detection tool measures the approximate frequency of the signa
140. y 25 105 Test Stimulation 58 77 105 Theory of Operation 21 Therapy limit per day 76 106 Therapy disabling 76 Torque driver 23 Training Program RNS System 10 Transcranial Magnetic Stimulation TMS Contraindication 9 Troubleshooting 84 Damaged Products 84 ECoGs 86 Error Messages 84 Low Battery Measurement 88 Neurostimulator Programmer Communication 87 Programmer 87 Tunneling 24 45 46 106 Tunneling Straw 24 Tunneling Tool 24 106 Tunneling Tool Tip 24 Turn OFF therapy 76 Typographic conventions 6 U Ultrasound 17 Use by date 26 Ww Wand 25 Cleaning and Sterilization 26 Testing the Wand Signal 55 Warnings 10 Clinical Use 10 Medical Environment 13 Programmer 13 RNS System and Therapy 11 Surgical 10 Warnings and Precautions 10 X X ray 17 86 NeuroPace Inc 455 N Bernardo Ave Mountain View CA 94043 Customer Support 1 866 726 3876 Toll Free in the US Fax 650 237 2855 Website www NeuroPace com qa lt NEUROPACE RNS System User Manual
141. y support the proximal ends of the Lead at their exit point from the Neurostimulator Line length detection tool The line length detection tool performs an estimate of the length dimension of a signal related to the complexity of a signal Long episode Initiate ECoG storage when a detected episode continues beyond a preset duration Magnet The Magnet suppresses RNS System therapy as long as the Magnet is in position Placing the Magnet over the Neurostimulator also triggers a diagnostic and can also be programmed to trigger ECoG storage Measurements Programmer display of measurements of the Neurostimulator Lead impedances battery voltage and charge time RNS System User Manual Glossary 104 Measurement current The selected current which will be delivered in order to obtain a commanded impedance measurement Montage Collective term used to describe the assignment of electrode labels and amplifier gain settings to the amplifier channels Noise 1 An event detector that identifies 60 Hz noise from selected detect channels 2 Environmental interference in the telemetry between the Neurostimulator and Wand Programmer Non interactive Session A programming session that is activated from the Programmer s main menu Overwritten Once the memory for ECoG or diagnostics is full the Neurostimulator will store new data by overwriting the oldest ECoG records or diagnostics Patient Data Management System PDMS The PDMS is a

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