SALUDA MEDICAL Evoke SCS System Clinical Manual Download Page 1

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Evoke

SCS System Clinical Manual

CLIN-UMAN-005175

Revision: 9.00

Page 1 of 101

Evoke® SCS System Clinical Manual

Use of the Evoke Clinical Interface (CI) and Clinical Programming
Application (CPA) with the Evoke Clinical System Transceiver (CST) for
programming the Evoke SCS System

Summary of Contents for Evoke SCS System

Page 1: ...UMAN 005175 Revision 9 00 Page 1 of 101 Evoke SCS System Clinical Manual Use of the Evoke Clinical Interface CI and Clinical Programming Application CPA with the Evoke Clinical System Transceiver CST...

Page 2: ...W 20 6 8 CHOOSE THE STIMULATION ELECTRODES AUTOMATICALLY 20 6 9 START AND STOP STIMULATION WITH CLOSED LOOP DISABLED 21 6 10 SET UP ECAP MEASUREMENT 23 6 11 SET UP CLOSED LOOP STIMULATION 29 6 12 SET...

Page 3: ...11 5 SECURE THE ECLS FOR THE TRIAL STIMULATION PERIOD 77 12 BEHAVIOUR OF THE STIMULATOR WHEN ALERTS OCCUR 77 12 1 OUT OF COMPLIANCE 77 12 2 REFERENCE CLOCK ERROR 78 12 3 ELECTRODE DISCONNECTED 78 12 4...

Page 4: ...Australia All rights reserved Refer to the Evoke SCS System Surgical Guide for System warnings and precautions Instructions on the implantation of the Evoke System components Other system component d...

Page 5: ...amplitude is a measure of the spinal cord activation or number of dorsal column fibers in the spinal cord that are activated by a stimulation pulse When closed loop is enabled the system automatically...

Page 6: ...atio of stimulation current between stimulation sets and pulse timing pulse width frequency interphase gap and inter stimulus interval 1 3 Measurement Features The Evoke System supports the following...

Page 7: ...ofile NRP The neural response profile is a set of objective measures characterizing the spinal cord activation levels experienced by the patient while using their stimulator Activation level ECAP ampl...

Page 8: ...ads and measures the neural response to stimulation 1 4 3 Evoke eCLS Case Ref No 3035 The Evoke eCLS Case is used by the patient to house the eCLS during the trial stimulation period The kit also incl...

Page 9: ...ached to the Charger is placed over the CLS and charge is transferred to the CLS through thin clothing and the skin The Charger kit also includes a power adapter for recharging the Charger 1 4 9 Evoke...

Page 10: ...refer to the Evoke SCS System Surgical Guide accessible at http www saludamedical com manuals The Evoke CI is based on a tablet computer For non therapy specific warnings and precautions on this produ...

Page 11: ...dditionally any stimulator software upgrades will be fully supported by Saluda Medical representatives do not attempt to modify the stimulator software without Saluda Medical s instruction 4 1 5 Non s...

Page 12: ...CI The CI is a tablet computer For full specifications and instructions for use of the the tablet computer refer to the device manual accompanying the CI tablet The computer is not physically modified...

Page 13: ...he time and date on the CI are correct bottom right corner of CI screen Refer to the CI instructions see Section 5 1 for link to change the time and date 3 Connect the CST to the CI with the USB conne...

Page 14: ...Section 13 1 available at all times during the programming session in case they are needed to stop stimulation refer to the Evoke SCS System User Manual Stimulation Settings hidden ECAP measurement ba...

Page 15: ...ed data from the stimulator Note When the CPA connects to a stimulator it will attempt to download three log files from the stimulator If any logs cannot be downloaded an error message will be display...

Page 16: ...tructions on charging the CLS battery or Section 11 4 for charging the eCLS battery Figure 6 4 CLS icon with stimulator battery voltage indicator 6 4 Retrieve or set the Patient ID and Patient Zone 6...

Page 17: ...e Patient ID will be automatically updated in the stimulator when you start stimulation 4 Navigate to the settings page by opening the navigation menu and touching Settings see Figure 6 7 Select the a...

Page 18: ...ces Measure the electrode impedances to determine if all connections are intact between leads any lead adapters and the stimulator 1 Touch the Impedance icon Note The icon will spin during the measure...

Page 19: ...on If the electrodes show an open circuit i e disconnected Wipe any blood or fluid off the lead connection contacts If the system is fully implanted a high impedance may indicate that the lead is brok...

Page 20: ...nse ECAP to stimulation see Section 6 10 4 Determine the settings for optimum closed loop stimulation see Section 6 11 and 6 13 5 Save the program to the eCLS CLS memory see Section 6 15 and proceed t...

Page 21: ...rwise you can adjust the individual stimulation parameters in order to adjust paresthesia coverage e g Pulse Width and or different sensation e g Stimulation Frequency in the stimulation settings menu...

Page 22: ...to start stimulation with closed loop disabled Note The arrow will change orientation to an Up arrow for increasing stimulation current and various areas of the screen will become active e g the ECAP...

Page 23: ...Touch the Stop button to stop stimulation at any time 6 10 Set up ECAP measurement The stimulator records the ECAP signal and displays a plot of the ECAP on the programming screen Figure 6 14B ECAP me...

Page 24: ...using the measurement electrode scan to optimize the choice of measurement electrodes and settings The ECAP display Figure 6 15 shows the average ECAP estimate for each measurement electrode configur...

Page 25: ...etermine the measurement electrode configuration with the optimal ECAP based on size shape and or largest Signal Quality Indicator SQI value see Section 6 16 a Enabling ClearCAP Virtual Ground may imp...

Page 26: ...ote The default filter has a negative first peak see Figure 6 16 In some cases filter alignment may be improved by flipping the filter the first peak is positive This is done by changing the measureme...

Page 27: ...peaks aligned with the ECAP signal The first peak is positive and the Processing Period and Filter Frequency are adjusted to align the filter see Section 6 10 steps 6 and 7 The ECAP signal is also re...

Page 28: ...nclude 1 Sampling Period The number of samples of the signal to record see Section 8 2 The Sampling Period default 3662 s must be greater than or equal to the Processing Offset plus the Processing Per...

Page 29: ...Figure 6 14F following these steps 1 Optimize the ECAP measurement refer to Section 6 10 2 Increase current from near paresthesia threshold to a strong level e g the maximum that the patient could to...

Page 30: ...for guidelines on determining appropriate values The limits both stimulation current and ECAP target should be tested to ensure that the stimulator has enough range to allow the patient to receive the...

Page 31: ...Set between 0 1 and 0 3 mA depending on the current range between Threshold and Maximum activation plot levels in the sitting posture see Section 7 6 Increase the increment if each step has no notice...

Page 32: ...ot to see how the closed loop control responds The ECAP amplitude will show some variability but the average ECAP amplitude should track the target level Figure 6 22 and changes in current should trac...

Page 33: ...ar Figure 6 22 1 If therapy is stopped touch the Start CL Stimulation arrow Note The arrow will change orientation to an Up arrow for increasing the ECAP amplitude target and various areas of the scre...

Page 34: ...Touch the Stop button to stop stimulation at any time 6 15 Save a program to the stimulator The CLS and eCLS can each hold up to four different programs The four program slots display the programs cur...

Page 35: ...m number to the desired program slot for the new program Note You should save the programs to a save slot see Section 6 15 3 before overwriting a program in case you want to restore a previous one 6 1...

Page 36: ...single stimulation set see Section 7 5 first select the stimulation set you want to load the saved stimulation set into 3 Touch the desired save slot and choose Restore a You may restore all the prog...

Page 37: ...ent stimulation current pulse width and interphase gap The inter stimulus interval is configurable for each program 7 1 1 Pulse shape and polarity Each pulse can be configured to have two biphasic or...

Page 38: ...Figure 7 1 repeats at a set frequency The stimulation frequency can be customized for each program see Section 8 1 7 2 ClearCAP ClearCAP is used to reduce the artefact recorded during measurement by c...

Page 39: ...sing when ClearCAP is enabled 7 3 Current steering Current steering is available whenever there is more than one stimulating electrode to balance the strength of paresthesia felt in different areas of...

Page 40: ...and 1 to 3 other configurations The configurations used in the scan are displayed in the measurement electrode scan window Figure 7 4 along with the Signal Quality Indicator SQI see Section 7 4 2 The...

Page 41: ...a signal resulting from the stimulus pulse that is not related to neural activity but can interfere with measurement of an ECAP The CPA estimates the ECAP and artifact from the recorded signal so tha...

Page 42: ...verage artifact estimate subtracted thin line e g Figure 7 5 ECAP display A Raw B Scrubbed simple C Scrubbed detailed with up to 4 colors representing each measurement configuration Note The recommend...

Page 43: ...to determine the optimal settings for ECAP measurement Note If an ECAP is present in the ECAP signal the SQI value may gradually increase with time i e if the confidence in the ECAP estimate increases...

Page 44: ...rther Fixed Reference electrodes from selected 1 closer 1 further 2 further As selected Fixed Distance electrodes from selected 1 closer 1 further 2 further 1 closer 1 further 2 further Disable Enable...

Page 45: ...r You may change the default in the settings screen see Section 8 6 1 Navigate to the settings page by opening the navigation menu and touching Settings see Figure 6 7 2 You may change the setting Mea...

Page 46: ...to run in Ungrouped mode a Configure the new stimulation set with the desired stimulation settings see Sections 6 8 to 6 9 b Set the current to the patient perception threshold and touch the Threshol...

Page 47: ...e closed loop stimulation as per Section 6 13 Note Closed loop stimulation will only operate based on the settings in the applied stimulation set The closed loop control will vary the current to each...

Page 48: ...r to Section 7 5 3 All enabled Stimulation Set A disabled Figure 7 9 Left Original current levels with all stimulation sets enabled Right Current levels with stimulation set A disabled 7 5 3 Changing...

Page 49: ...red comfortable sensation for increasing or decreasing stimulation respectively c Maximum M When the patient could tolerate stimulation for no more than approximately one minute Note When marked the b...

Page 50: ...lly increase the stimulation current or target to the next activation plot level or the level when stimulation was last stopped solid line in Figure 7 11B Note If stimulation is stopped the Ramp Up bu...

Page 51: ...the clinical data log file e g A screenshot of the CPA programming screen is also saved in a Screenshot folder for the relevant visit on the CI 7 7 3 Screenshots 1 Touch the Communication Quality Indi...

Page 52: ...te the chronaxie and rheobase of the stimulated neurons See Section 7 8 2 Perform a Conduction Velocity Measurement Collect data to estimate the conduction velocity of evoked neural responses in the d...

Page 53: ...measurement defaults 6 Touch No if you wish to use the existing program parameters Note The pulse width must be greater than 240 s 7 Start stimulation with closed loop disabled and then touch Continue...

Page 54: ...tomatically moves the measurement and reference electrode if applicable at a fixed current level To perform a conduction velocity measurement 1 Choose the stimulation electrode configuration and setti...

Page 55: ...the stimulation is at the maximum level M can tolerate for approximately 1 minute Then reduce the current until the patient reports it has returned to a comfortable level C 10 Touch Continue to begin...

Page 56: ...Wait for the measurements to complete The test will cycle through up to 6 stimulation locations until the lead offset can be confidently calculated Note You may stop the lead offset test at anytime by...

Page 57: ...es Load from file Measure the impedances between electrodes specified in a csv file Note The file will be provided by Saluda Medical Field Clinical Engineer FCE if required Note The impedance measurem...

Page 58: ...y session list 7 10 1 Start Survey 1 Touch the New Session button to create a new survey Figure 7 16 a For a new patient a Setup survey will be created b For an existing patient a Follow Up survey wil...

Page 59: ...Width 20 1000 s Program Parameters Stimulation Frequency Hz 10 1500 Hz closed loop disabled 10 250 Hz closed loop enabled Maximum stimulation current 1 50 mA Current Increment 0 05 mA 4 0 mA dependin...

Page 60: ...CAP amplitude vs processing offset Open circle recommended offset peak of plot black line offset used Press Apply to use recommended offset Filter Frequency Filter mode only 496 1928 Hz 65 16 samples...

Page 61: ...select the measurement electrode ECAP amplifier positive input required and all the other electrodes remain the same Note Can be changed during stimulation if closed loop is disabled Reference electr...

Page 62: ...LS icon displays the status of the stimulator Connected to CLS Connected to eCLS Demo stimulator Stimulator is disconnected CLS time is not synchronized CST is disconnected Stimulator battery voltage...

Page 63: ...e program Clear Program Clear the selected program from the stimulator Lead Configuration Switch between different lead types Download Usage Logs Download usage logs from stimulator Download Therapy L...

Page 64: ...bol is displayed over the mode not in use CL cannot be disabled with EPC CL cannot be enabled with EPC Soft Reset Reset stimulator clear Safe Mode errors clear programs and reconnect Log Setup Set up...

Page 65: ...ns Close navigation menu Quit Close CPA stimulation will continue if on Survey Go to the patient survey screen see Section 7 9 Settings Go to the settings screen see Section 8 6 Programming Go to the...

Page 66: ...the region or zone for the patient Stim Set Parameters Set Defaults Set settings menu values to defaults for the selected stimulation set Stimulation Set selection Stimulation set slots labeled A B C...

Page 67: ...hecked Measurement Electrodes Scan Enabled on Device Connection Disable not checked or enable checked the Measurement Electrode Scan on connection to a device PCLCS Supervisor Charger Mitigation Enabl...

Page 68: ...d errors see Section 12 Figure 8 2 Alert and error display and alert counts on the programming screen Table 8 1 Alert count symbol information Note that a means the corresponding log was not downloade...

Page 69: ...A Safe Mode error is also indicated with the Contact Clinician indicator on the patient EPC and Charger see Evoke SCS System User Manual If a Safe Mode error is encountered 1 Use the CPA to reset the...

Page 70: ...uired for the various procedures Note Neither the CI or the CST are supplied sterile and should not be used inside the sterile field see Evoke SCS System Surgical Guide for details Following lead plac...

Page 71: ...f the pain areas If confirmation of optimal lead placement will be based on ECAP measurement go to Section 9 2 1 If paresthesia mapping is to be performed go to Section 9 2 2 9 2 1 ECAP measurement Th...

Page 72: ...the patient reports a strong but comfortable level of paresthesia tingling 5 The patient should report paresthesia coverage of the dermatomes that align with their pain area s If paresthesia coverage...

Page 73: ...purpose of a temporary trial refer to Section 11 below to prepare the eCLS for the trial stimulation period Programming should be conducted as described in Section 6 11 Prepare the eCLS for the trial...

Page 74: ...he top of the slot The lead should not move when fully pushed into the slot After the lead is in the slot press down again along its length to ensure it is secure in the slot Figure 11 2 Pushing lead...

Page 75: ...the end of the lead adapter plug with the socket on the eCLS port to ensure the connector pins do not get bent Figure 11 4 Push the lead adapter plug into the eCLS until it clips into place a The eCLS...

Page 76: ...lace the eCLS with leads connected into the eCLS Case 4 Close the eCLS case by folding the case shut until it snaps closed Figure 11 6 Ensure that the leads do not move from the slots in the seal The...

Page 77: ...ur Refer to Section 8 7 for alert and error display on the CPA 12 1 Out of compliance Out of compliance OOC occurs when the voltage requirement exceeds the maximum stimulation voltage see Section 8 6...

Page 78: ...hen the stimulator stopped 12 4 Current at maximum If the stimulation current is at its maximum setting when closed loop is enabled stimulation may stop or the patient may feel a reduction in paresthe...

Page 79: ...stimulation once the ECAP signal is detected The system determines an ECAP has been detected when the ECAP amplitude reaches half the original target value If closed loop is disabled and clipping occu...

Page 80: ...Section 13 1 Note You do not need to un pair the EPC from the stimulator it is already connected to before pairing with a different stimulator 14 Evoke Charger Refer to the Evoke SCS System User Manua...

Page 81: ...ing starts and the stimulation current is set to the minimum from the previous 10 seconds 5 After charging has finished the CLS will automatically enable closed loop stimulation If stimulation was on...

Page 82: ...Refer to the Evoke SCS System User Manual for advice on the maintenance of additional components of the Evoke SCS System 16 3 Updating the Evoke CI Software The CI contains software that automaticall...

Page 83: ...f the CI or the CST in municipal waste facilities Please return any items to Saluda Medical via your Saluda Medical representative for proper disposal 18 Troubleshooting Table 18 1 Troubleshooting Iss...

Page 84: ...t be off Unable to start stimulation on CPA Minimum electrode configuration has not been programmed Configure stimulation and return electrodes see Section 6 8 Stimulation parameters may be too high C...

Page 85: ...e Disconnected If an eCLS Check intraoperative cable lead adapter and eCLS connections Perform an impedance check to ensure all connections are ok If a CLS Perform an impedance check to ensure all con...

Page 86: ...edances See Electrode Disconnected CL stimulation is on when charging is started Turn off the Charger and see if the problem persists Out of Compliance Voltage limit may be too low Confirm voltage lim...

Page 87: ...ystem 20 1 1 Evoke CI Tablet specifications The CI tablet computer has minimum hardware specifications as follows Table 20 1 Evoke CI tablet minimum hardware specifications RAM 8 GB Storage 128 GB USB...

Page 88: ...te Antenna type Antenna Gain 300 kHz Frequency Shift Keying FSK 200kbs Internal PCB mounted antenna 8 7dB manufacturer s data Range 1 0 m 3 3 ft Effective Isotropic Radiated Power EIRP 25 W 16 02 dBm...

Page 89: ...in Do not operate other wireless devices such as a mobile phone tablet or laptop at the same time 20 2 2 Wireless Security The Evoke SCS System has a communication range of 1 meter 3 3 feet To enable...

Page 90: ...S System is unlikely to produce electromagnetic interference with nearby electronic equipment Conducted Emissions 0 15 MHz 30 MHz CISPR 11 EN 55011 Class B Evoke SCS System is suitable for use in all...

Page 91: ...commercial or hospital environment If the user of the Evoke Charger power adapter requires continued operation during mains power interruptions it is recommended that the Evoke Charger power adapter...

Page 92: ...h use is necessary this equipment and the other equipment should be observed to verify that they are operating normally Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment...

Page 93: ...ent from that to which the receiver is connected Consult the dealer or an experienced radio TV technician for help FCC Caution Any changes or modifications not expressly approved by the party responsi...

Page 94: ...cord activation The population of spinal cord nerve fibers in which ECAPs are initiated in response to stimulation Activation may be estimated by ECAP amplitude Activation Plot A plot of activation a...

Page 95: ...e the rheobase current Chronaxie is also known as the excitability constant or membrane time constant ClearCAP Virtual Ground A feature of the stimulation pulse that is used to reduce the artefact rec...

Page 96: ...inal cord tracts such as the dorsal column or to synapse in the dorsal horn Electrode An electrical contact that may be employed to deliver stimulation current or measure neural responses ECAP Amplifi...

Page 97: ...tus Error Log A time stamped record of alert and error events associated with stimulation Therapy Log A record of current ECAP amplitude and target for each stimulation pulse accumulated and compresse...

Page 98: ...ion Set A set of stimulation parameters designed to target a particular area of the patient s pain Strength Duration Curve A plot of the threshold current versus pulse width The strength duration curv...

Page 99: ...erial number Lot number YYYY MM DD Use by date YYYY year MM month DD day Temperature limitation F and C Manufacturer YYYY MM DD Date of manufacture YYYY year MM month DD day Do not dispose of this pro...

Page 100: ...diameter Protected against vertically dripping water when the device is tilted 15 IP30 Ingress Protection Rating 30 Protected against ingress of solid foreign objects greater than or equal to 2 5 mm...

Page 101: ...r website www saludamedical com and or www saludamedical com manuals If you have any further questions please contact your Saluda Medical representative Alternatively you can contact us via the detail...

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