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Introduction

RNS

System User Manual

NTRODUCTION

ONTACTING

EURO

ACE

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

BOUT THIS

ANUAL

This manual is intended to 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

•

Introduction

- Overview of the typographical conventions and contents of the manual

•

RNS

System Description

- Indications, contraindications, product descriptions, theory of

system operation, warnings, and precautions

•

Clinical Use of the RNS

System

- Physician and center access, identifying candidates,

pre-surgical planning, patient training, overview of implantation and initial programming

recommendations

•

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

•

Patient Follow-Up

- Guidelines for follow-up appointments, follow-up activities, and patient

counseling

•

Troubleshooting

- Information that may be helpful in solving problems encountered while

implanting or operating the RNS

System

•

Specifications

- List of each product with its mechanical and electrical characteristics

•

Glossary

- Alphabetical list of terms used in the manual with their definitions

Содержание NeuroPace CL-315-10

Страница 1: ...Rev Date 2019 01 DN 1017309 Rev 4 RNS System User Manual 2019 NeuroPace Inc ...

Страница 2: ...WBW5200 or 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 Certi...

Страница 3: ...G Storage Settings 30 Recommended Initial Responsive Therapy Settings 31 Modifying Detection and Responsive Therapy Settings 32 SURGICAL PROCEDURES 33 PRE IMPLANT 33 RECOMMENDED IMPLANT PROCEDURE FLOW CHART 35 RECOMMENDED NEUROPACE DEPTH LEAD IMPLANTATION AND FIXATION 36 RECOMMENDED NEUROPACE CORTICAL STRIP LEAD IMPLANTATION AND FIXATION 39 RECOMMENDED RNS NEUROSTIMULATOR IMPLANTATION PROCEDURE 40...

Страница 4: ...bling or Changing Responsive Therapy 76 Recommended Initial Responsive Therapy Settings 77 Recommended Modifications to Responsive Therapy Settings 80 Programming the Newly Selected Settings 80 REVIEWING REPORTS 81 MAGNET 82 PATIENT FOLLOW UP ACTIVITIES 83 TROUBLESHOOTING 84 DAMAGED PRODUCTS 84 GENERAL TROUBLESHOOTING ACTIVITIES 84 Abnormal Lead Impedance greater than 3500 Ohms or less than 250 Oh...

Страница 5: ... appropriate product for symbols that apply Caution Do Not Resterilize MR Unsafe Prescription Only Non Pyrogenic Single Use Sterilized Using Ethylene Oxide Use Temperature limits during use Storage Temperature limits during storage or transport Manufacturer Serial number Type BF applied part ...

Страница 6: ...liquids which means testing confirms vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15 from its normal position Ethernet Connection Network Connection Proposition 65 a State of California voter initiative requires the following notice WARNING This product can expose you to chemicals including ethylene oxide which is known to the State of Calif...

Страница 7: ...iptions theory of system operation warnings and precautions Clinical Use of the RNS System Physician and center access identifying candidates pre surgical planning patient training overview of implantation and initial programming recommendations Surgical Procedures Instructions for implanting the RNS System Instructions for Use Description of the settings available in the neurostimulator and instr...

Страница 8: ...pecial 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 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 tex...

Страница 9: ...Introduction 7 RNS System User Manual The tabs are displayed on the NeuroPace Programmer screen as follows Tab Page Button ...

Страница 10: ... 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 prosthesis remain MR imaging is contraindicated for patients with an implanted RNS System Do not perform an MRI on a patient with any implanted RNS Neurostimulator ...

Страница 11: ...logists 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 train...

Страница 12: ...ss and may require additional surgical procedures to modify the lead location WARNING PREGNANT WOMEN The safety and effectiveness of the RNS System has not been studied in pregnant women WARNING RNS SYSTEM 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 failu...

Страница 13: ...FID 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 should be aware of possible sensing artifacts when assessing the ECoG recordings Potential sources of RFID may occur in a health care environment retail stores ...

Страница 14: ...OMPONENTS Use of accessories transducers and cables other than those provided by NeuroPace could result in increased electromagnetic emissions or decreased electromagnetic immunity of the RNS System and result in improper operation Do not plug the wand into equipment other than the programmer because it could damage the wand Do not use a USB cable extension from the programmer to the wand WARNING ...

Страница 15: ...ING COMPUTERIZED TOMOGRAPHY CT SCANS For CT procedures on a patient with an implanted RNS Neurostimulator the operator should Ask the patient to have the neurostimulator temporarily shut off with a programmer while the scan is performed if possible Minimize x ray exposure to the implanted electronic medical device by Using the lowest possible x ray tube current consistent with obtaining the requir...

Страница 16: ...tabilize the lead Suturing directly on the lead may cause lead body damage and malfunction PRECAUTIONS RNS SYSTEM AND THERAPY 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 Precaution Battery Depletion For cont...

Страница 17: ...o a grounded power source PRECAUTIONS MEDICAL ENVIRONMENT 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 fun...

Страница 18: ...tient 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 Diagnostic x rays Diagnostic ultrasound Precaution Other Active Implanted Medical Devices RNS Syste...

Страница 19: ...eo 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 bee...

Страница 20: ...sterile external products Implantable RNS System Products The sterile implantable products are the RNS Neurostimulator NeuroPace Cortical Strip Lead s and NeuroPace Depth Lead s Implantable components and accessories External RNS System Products The non sterile external products are the NeuroPace Programmer laptop computer with proprietary software and telemetry component wand model W 02 used for ...

Страница 21: ...on 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 Magnet used by the patient to withhold therapy or to trigger electrocorticographic ECoG storage Figure 2 RNS Neurostimulator with two NeuroPace leads Cortical Strip Lead Connector Cover Depth Lead Lead Strain Relief Depth Lead De...

Страница 22: ...ty 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 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 ...

Страница 23: ...ts 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 WARNI...

Страница 24: ...wing lengths 15 centimeters model CL 315 10 25 centimeters model CL 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...

Страница 25: ...e 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 compone...

Страница 26: ...the laptop component of the programmer via a USB cable NEUROPACE PATIENT DATA MANAGEMENT SYSTEM NeuroPace Patient Data Management System Model 4340 The Patient Data Management System PDMS maintains patient and product data obtained from the 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 nam...

Страница 27: ...rned 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 con...

Страница 28: ...lated utilizing three patient use profiles Low 5th Percentile Medium 50th Percentile and High 95th Percentile It is important to note that the RNS Neurostimulator 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 Battery Capacity mAh Longevity Estimate years Low 5 th Percent...

Страница 29: ...e 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 neu...

Страница 30: ...l 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 ...

Страница 31: ...ATION 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 the focus it is possible that the seizure fo...

Страница 32: ...M 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 m...

Страница 33: ... 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 µsec and burst duration of 100 ms Current amplitude should be initially programmed at 1 0 mA In general stimulation s...

Страница 34: ... 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 t...

Страница 35: ... Manual outlines this information and should be provided to and reviewed with the patient prior to the RNS System implant Pre surgical Antibiotics 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 pro...

Страница 36: ...1 Go to 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...

Страница 37: ...dvance Depth Lead to target depth Secure Depth Lead using Burr Hole Cover Cap Make Burr Hole at appropriate location to implant Depth Lead Cortical Strip Lead Implant Depth Lead Implant Tunnel Leads to Neurostimulator 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 Conne...

Страница 38: ...d follow the manufacturer s Instructions for Use Note It is 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 ho...

Страница 39: ...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 lea...

Страница 40: ...k 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 7 Place lead caps provided on the proximal end of unconnected leads and place the excess lead in a sub ga...

Страница 41: ...t the stylet into the lead after it has been removed 2 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 point where stabilization is desired Then use non absorbable sutures to ligate the suture slee...

Страница 42: ...er from only one direction Review the neurostimulator orientation and lead exit point prior 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 The portion of the incision that will need to be re opened to replace the neurostimulator should ...

Страница 43: ...debris from the areas inside and surrounding the craniectomy 2 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 3 Bend the three straight ferrule tabs to the appropriate depth using a needle driver or ...

Страница 44: ...h 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 ...

Страница 45: ... System User Manual 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 ...

Страница 46: ...e scalp until the tunneling tool tip exits near the burr hole 6 Once the tool has exited the burr hole unscrew and remove the tip 7 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 8 Gently slide the proximal end of the lead into the tunneling tool straw 9 Advance the lead from t...

Страница 47: ... and Lead s 1 Hold the connector cover with the windows visible 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 ...

Страница 48: ...rostimulator 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 neurostimulator using the torque driver Ensure that the leads remain completely inserted in the con...

Страница 49: ...connector cover Figure 16 and attach it to the post 11 Cover the 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 clo...

Страница 50: ... 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 2 Proceed with the interrogation 3 Go to the PROGRAM SETTINGS tab and select program 4 Synchroniz...

Страница 51: ...ostimulator 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 12 Place the new neurostimulator in the ferrule 13 Secure the neurostimulator to the ferrule by rotating the ferrule clamp into position over the neurostimulator and tightening the ferr...

Страница 52: ... relieve stress on the lead 27 Cover the wand with a sterile bag and position it over the neurostimulator 28 Program the new neurostimulator with the same settings as the explanted neurostimulator 29 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 I...

Страница 53: ... if requested 9 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 10 Flush the craniectomy and ferrule 11 Place the cranial prosthesis in the ferrule 12 Secure the cranial prosthesis to the ferrule by rotating the ferrule clamp into position over the cranial prosthesis and tighten...

Страница 54: ...hen 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 15 Fully attach the connector cover to the neurostimulator by tightening the screw until the torque driver clicks 16 Place the lead strain relief over the p...

Страница 55: ...t the leads into the connector cover and repeat the impedance measurements Refer to the Troubleshooting Section if impedance 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 It is common for the neurostimulator to reset if ele...

Страница 56: ... 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 ...

Страница 57: ...tton 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 conti...

Страница 58: ...ATOR ACTIVITY INFORMATION The summary page displayed 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 neuros...

Страница 59: ...rsts 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 a...

Страница 60: ...a Management System PDMS upon neurostimulator reprogramming or collection of new neurostimulator 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...

Страница 61: ...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 ASSIGNIN...

Страница 62: ...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 is assigned automatically Electrode numbers 1 4 are assigned automatically Figure 20 For both the depth lead and cortical strip lead electrodes are numbered 1 through 4 Electrode 1 is the most distal ...

Страница 63: ...1 RNS System User Manual Recommended Initial Lead Labels 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 Figure 21 Patient Product tab ...

Страница 64: ... 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 CH 1 Lead 1 Electrode 1 ...

Страница 65: ...capture duration 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 Go t...

Страница 66: ...the RNS System This trigger can be used whenever detection is ENABLED MAGNET triggers initiate ECoG storage when a magnet is passed by the RNS Neurostimulator Selecting this trigger may be helpful in storing electrographic events that correspond to clinical symptoms experienced by the patient SCHEDULED triggers initiate ECoG storage at a specific time of day ECOG STORAGE START TIMES Selecting this...

Страница 67: ...Programming Instructions 65 RNS System User Manual Figure 24 ECoG Storage tab ...

Страница 68: ...red 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...

Страница 69: ...ot 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 The LENGTH OF STORED ECOG value may be increased if longer ECoGs are desired and decreased if a larger number of ECoGs are desired Figure 26 ECoG Storage tab Programming the Newly Selected ECoGs Storage Se...

Страница 70: ...A default file for a one or a two lead configuration A file previously created developed and saved during a configure detection session A file retrieved from the neurostimulator during interrogation and generated using the SAVE button A file downloaded from the PDMS and accepted 4 If desired modify the detection set by adjusting specific detection parameters 5 Simulate the performance of the newly...

Страница 71: ...etection Settings Initially in order to capture ECoGs containing activity that can be used to configure detection settings specific to the patient program initial detection settings on the DETECTION tab as follows Select Default Line Length 75 on Ch 1 3 Click on the name Set detection status to ENABLED Figure 28 Detectors tab ...

Страница 72: ...ther using the PDMS or the NeuroPace Programmer to configure detection Line length detector The line length detector provides detection of power a type of ECoG activity To understand how the line length detector works imagine the ECoG as a string that can be stretched so the length can be measured see Figure 29 ECoGs with higher amplitude or frequency oscillations will have longer length The line ...

Страница 73: ...operates by comparing the normalized ECoG area area per second in a short term trend window typically 1 to 4 seconds to the normalized ECoG area in a long term trend window typically 1 to 2 minutes When the difference between the short term and long term trend windows exceeds a programmed threshold typically 37 5 to 100 detection occurs Figure 30 Area detector example ...

Страница 74: ... to be detected As minimum duration is decreased the detector will become more sensitive and it will take less time for a signal at a given frequency to be detected Figure 31 Bandpass detector example 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 acce...

Страница 75: ...rove 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 After several ECoGs with activity have been stored a bandpass detector should be considered if the activity has a stereotypical frequency ...

Страница 76: ...ns 74 RNS System User Manual 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 ...

Страница 77: ...fferent bursts may be delivered in response to a specific event detector Pattern A or Pattern B as depicted in Figure 34 or Up to two bursts may be selected to be delivered 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 Figure 34 A THERAPY SEQUENCE DELIVERED IN RESPONSE TO A SPECIFIC EVENT ...

Страница 78: ...he stimulation 2 Select the level of CURRENT that will be delivered 3 Select the BURST DURATION to determine the length of the stimulation burst 4 Select the PW PER PHASE to determine the duration of each phase of the biphasic current pulse 5 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 s...

Страница 79: ...ally electrode to can to determine whether there are acute side effects from stimulation Habituation to side effects resulting from stimulation has been observed however it is not advised to program settings that cause patient discomfort Avoid stimulation settings that cause an electrographic afterdischarge Note Test stimulation can be performed from the TEST STIMULATION screen or by selecting the...

Страница 80: ...Programming Instructions 78 RNS System User Manual Figure 36 Therapy testing screen ...

Страница 81: ...terest 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 FREQUENCY 200 Hz PW PER PHASE 160 µs BURST DURATION 100 ms Copy THERAPY 1 settings to THERAPY 2 through THERAPY 5 Program settings into the neurostimulator on the PROGRAM SETTINGS tab Figure 37 Therapy 1 tab ...

Страница 82: ...apy 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 ...

Страница 83: ... 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 4 Select RESPONSIVE THERAPY to be ENABLED 5 Select the PROGRAM SETTINGS tab 6 Select REVIEW CHANGES to view changes prior to programming 7 Select the PROGRAM button REVIEWING REPORTS Reports containing th...

Страница 84: ...ed to do so Inform the patient about the proper use of the magnet Information about the Magnet While the magnet is placed within one inch of the neurostimulator therapies are not delivered Therapies are re enabled upon removal of the magnet Detection and ECoG storage continue while the magnet is in place Each time the magnet is placed the time of placement is stored in the neurostimulator Test sti...

Страница 85: ...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 Ac...

Страница 86: ...ative Procedure The goal of the following procedures is to ascertain if the abnormal lead impedance measurement is associated with the lead or with the RNS 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 Disco...

Страница 87: ...tical 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 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 If the abnormal impedance is not associated w...

Страница 88: ...h lead impedance or the neurostimulator configuration settings If the first entries in the PDMS interrogation report event list show the Programmed current is higher than the Lowest delivered current as shown in the example image contact your NeuroPace Field Clinical Engineer The NeuroPace Field Clinical Engineer will help you review the lead impedances and neurostimulator configuration settings t...

Страница 89: ...ogrammer instructions in this section 3 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 Confirm that the wand cable is inserted securely into the USB port at the rear of the programmer 2 Confirm that th...

Страница 90: ...ator Test request was rejected by the neurostimulator Issue The neurostimulator cannot perform an impedance measurement or a test stimulation therapy testing Possible Cause The neurostimulator may be delivering therapy Impedance measurement or test stimulation cannot be performed during responsive therapy The neurostimulator may be detecting an episode Impedance measurement or test stimulation can...

Страница 91: ... 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 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 th...

Страница 92: ...RENT VOLTAGE REGULATED Current regulated MAX OUTPUT CURRENT AT 500 OHMS 11 5 mA 10 800 OHMS 9 6 mA 10 1200 OHMS 6 0 mA 10 MAX OUTPUT VOLTAGE AT 500 OHMS 6 0 V 10 800 OHMS 9 6 V 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 10 µC sec at 50 Hz 5 mA and 120 µsec phase LEAKAGE CURRENT NO OUTPUT 0 5 μA MAXIMUM CHARGE DENS...

Страница 93: ... amplitude modulation RF DATA FLOW CHARACTERISTICS Half duplex EFFECTIVE RADIATED POWER 224 pW or less RNS SYSTEM LEADS Cortical Strip Leads Depth Leads 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 LEAD BODY DIAMETER 1 27 mm 1 27 mm NUMBER OF ELECTRODES 4 4 ELECTRODE SPACING AVAILABLE 10 mm 3 5 mm and 10 mm CONDUCTOR RESISTANC...

Страница 94: ...cal OPERATING TEMPERATURE 0 C to 35ºC WAND MODEL W 02 DIMENSIONS LENGTH X WIDTH X DEPTH 7 x 3 5 x 1 3 18 cm x 9 cm x 3 cm WEIGHT 0 4 pounds 181 g POWER SOURCE USB port of the remote monitor laptop OPERATING CONDITIONS Temperature 32 to 95 F 0 to 35 C Humidity 15 to 90 non condensing Atmospheric pressure 700 to 1060 hPa MATERIAL ABS copolymer LEAST FAVORABLE WORKING CONDITIONS Wand output power and...

Страница 95: ... this happens refer to Poor or No Communication Between the RNS Neurostimulator and the Programmer on page 87 The neurostimulator is expected to recover all intended functions following the removal of the electromagnetic disturbance Hospital or Medical Environments Patients should always inform healthcare personnel that they have an implanted RNS System and show their medical implant identificatio...

Страница 96: ...ion Emissions and Immunity Information The programmer with wand are designed for use in a medical environment by a trained healthcare professional The remote monitor with wand are designed for use in the home by a patient 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 Note Unl...

Страница 97: ...wer supply input lines IEC 61000 4 11 0 UT 0 5 cycle 0 UT 1 cycle d 40 UT 5 cycles d 70 UT 25 cycles 0 UT 5 Sec If the user of the programmer and wand requires continued operation during power mains interruptions it is recommended that the programmer and wand be powered from an uninterruptible power supply or a battery Magnetic immunity IEC 61000 4 8 3 30e A m Power frequency magnetic fields shoul...

Страница 98: ... the ISM bands b Separation distance relevant to Programmer model PGM 300 and Remote Monitor model DTR 300 At 80 MHz and 800 MHz the higher frequency range applies c These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people d Field strengths from fixed transmitters such as base stations for radio cellula...

Страница 99: ... 33 10 3 69 3 69 7 38 100 11 67 11 67 23 33 a Separation distance relevant to Programmer model PGM 300 and Remote Monitor model DTR 300 At 80 MHz and 800 MHz the higher frequency range applies b These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people c For transmitter rated at a maximum output power no...

Страница 100: ...p FC 01 Lead Strain Relief LSR 01 Torque Driver TD 01 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 Nu...

Страница 101: ... 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 ...

Страница 102: ...K Item Model Number Craniectomy Template CT 01 Lead Strain Relief LSR 01 Torque Driver TD 01 Cranial Prosthesis Kit Model P 01 K Item Model Number Cranial Prosthesis P 01 Ferrule Clamp FC 01 Torque Driver TD 01 Connector Cover Kit Model CC 01 K Item Model Number Connector Cover CC 01 Connector Plugs 2 CP 01 Lead Strain Relief LSR 01 Torque Driver TD 01 Ferrule Kit Model F 01 K Item Model Number Fe...

Страница 103: ... 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 mar...

Страница 104: ...ct 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 craniectomy 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 curren...

Страница 105: ...sive 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 b...

Страница 106: ...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 com...

Страница 107: ...t would be detected using the proposed detection settings Stereotactic frame A medical device that is attached to the patient s head and provides 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 anode...

Страница 108: ...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 p...

Страница 109: ... 90 Cortical Strip Lead Explantation 9 Cranial Prosthesis 21 50 102 Cranial Tunneling Tool See Tunneling Tool Craniectomy 39 102 Craniectomy template 21 102 D Damaged packaging 25 33 Damaged products 83 DC Leak 87 Defibrillator 16 Depth Lead 102 Abandonment 50 Components and Accessories 23 Description 22 Handling 25 Implantation 29 35 Montage 58 83 104 Replacement 50 CHARACTERISTICS 90 Detection S...

Страница 110: ... measurement Implantation 29 39 Inactive mode 27 Initial Settings 29 30 60 61 63 68 76 Interrogation See Interrogation Longevity 26 Modifying Settings 31 65 69 79 Obtaining Activity Information 55 Patient Information 58 Programming 29 30 31 53 58 62 Recommended Settings 29 30 60 61 63 68 76 Recording ECoGs 29 54 62 63 Reset 27 47 49 52 87 105 Responsive Therapy 30 31 74 Reviewing ECoG Records 55 S...

Страница 111: ...ects 10 Surgical Procedures Abandoning Leads 50 Cortical Strip Lead Implant 29 38 Cranial Prosthesis 50 Craniectomy placement 39 Depth Lead Implant 29 35 Explanting RNS System 47 Implant Flowchart 34 Neurostimlator Leads Connection 43 Neurostimulator Ferrule Implant 39 Pre Implant 32 Replacing Leads 50 Replacing RNS System 47 Tunneling 43 44 Suture sleeve 105 Suture Sleeve 23 Symbols Glossary 3 Sy...

Страница 112: ...RNS System User Manual 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 ...

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