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SALUDA MEDICAL Evoke Clinical Manual

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Evoke™ SCS System Clinical Manual
Use of the Evoke System including recommendations for
programming the Evoke Closed-Loop Stimulator (CLS) and the Evoke
External Closed-Loop Stimulator (eCLS)
For Clinical Trial Use Only
CAUTION – Investigational Device.
Limited by Federal (or United States) law to investigational use.
Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 1 of 61

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Summary of Contents for SALUDA MEDICAL Evoke

  • Page 1 Evoke™ SCS System Clinical Manual Use of the Evoke System including recommendations for programming the Evoke Closed-Loop Stimulator (CLS) and the Evoke External Closed-Loop Stimulator (eCLS) For Clinical Trial Use Only CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use.

  • Page 2: Table Of Contents

    Table of Contents PRIVACY STATEMENT ...................... 3 DESCRIPTION ......................4 INDICATIONS FOR USE ..................... 5 CONTRAINDICATIONS ....................5 SAFETY INFORMATION ..................... 5 ........................5 ARNINGS .........................7 RECAUTIONS ......................11 OTENTIAL ISKS INTRA-OPERATIVE PROGRAMMING WITH THE CI ........... 12 ..............12 ONFIRMATION OF PTIMAL LACEMENT CLS C ..............14...

  • Page 3: Privacy Statement

    YMBOLS 18 CONTACT US ......................61 Trademarks Saluda, Evoke and the Saluda Medical logo are either trademarks or registered trademarks of Saluda Medical Pty Ltd. Copyright statement This work is copyright and may not be copied, reproduced or retransmitted without written permission from Saluda Medical Pty Ltd.

  • Page 4: Description

    1 Description The Saluda™ Medical Evoke™ System is a Spinal Cord Stimulation (SCS) system that can measure the Evoked Compound Action Potential (ECAP) and may provide consistent stimulation based on the subject’s neural response during physiological changes and movement by automatically adjusting the level of stimulation current required to meet the subject’s requested target level.

  • Page 5: Indications For Use

    Catalogue Number: 0024, 2024 The Evoke Clinical Interface (CI) is a tablet computer with a programming application used by the clinician to adjust the therapy settings in the Evoke CLS or Evoke eCLS. Name: Clinical System Transceiver (CST) Catalogue Number: 0004, 2004 The Clinical System Transceiver (CST) is a plug in device (USB connection) that enables exchange of information wirelessly between the CI and the stimulator.
  • Page 6  Patients implanted with the Evoke System should not be subjected to MRI as it may result in significant heating and/or tissue damage.  MRI exposure can damage the CLS, potentially requiring device explantation and replacement.  MRI exposure may also induce voltages through the leads and stimulator leading to unintended stimulation, such as tingling, shocking, or jolting.

  • Page 7: Precautions

     Implanting physicians should be trained in spinal cord stimulation (SCS) procedures.  Physicians should review the Evoke SCS System Surgical Guide before surgery. Medical therapies When used in close proximity to the Evoke System, the following medical therapies may turn stimulation off or cause damage to the CLS:  Lithotripsy ...
  • Page 8 Post-operative patient instructions After implant of the Evoke System, patients should take care to allow adequate healing and ensure that the leads and CLS do not move.  For six to eight weeks after surgery, patients should avoid: o lifting more than 2.2 kg (5 lbs);...
  • Page 9  If you have explanted any component of an Evoke System for any reason please contact Saluda Medical to arrange for its return. Modifications to components  The components of the Evoke System are not intended to be modified by users or surgeons in any way. 4.2.1 Unsupported software applications Do not load software applications onto the Evoke CI.
  • Page 10 Do not connect any device to the Evoke CI other than the supplied: keyboard, charger and Evoke CST. Do not connect the Evoke CST to any device other than a Saluda Medical supplied Evoke CI. Unsupported hardware could interfere in unpredictable ways with the programming software installed and affect the delivery of therapy for patients.

  • Page 11: Potential Risks

    CI in any way. If you have concerns about the integrity of the CI/CST contact Saluda Medical representatives to arrange repair or replacement. The CI runs on a rechargeable battery and can be used wirelessly or whilst plugged in via the power adapter supplied.

  • Page 12: Intra-Operative Programming With The Ci

    (see Evoke SCS System Surgical Guide for details). The surgeon passes the end of the lead adapter extension out of the sterile field to the programming clinician.
  • Page 13 5.1.2.1 ECAP measurement This section is to be completed by the programming clinician outside of the sterile field. Refer to Section 7 ‘Clinical Programming - Introduction’ for detailed programming instructions. 1. Connect the CI to the eCLS. 2. Check electrode impedance using the CI to ensure the leads are connected properly (see Section 8.5).

  • Page 14: Confirmation Of Proper Cls Connection

    1. Train the patient on use of the EPC, eCLS or CLS and guidelines for recovery after implant surgery (see Evoke SCS System User Manual). 2. If the patient has a CLS, also train them on correct use of the Evoke System Charger (see Evoke SCS System User Manual).
  • Page 15 Figure 6.1: Placing the tip of the proximal connector into the lead adapter slot. 2. Push the lead down into the slot completely using finger (see Figure 6.2), so that the lead is flush with the top of the slot. The lead should not move when fully pushed into the slot.
  • Page 16 Figure 6.3: Placing the top cover over the lead and sliding onto lead adapter until it clips into place. 4. Line up the end of the lead adapter plug with the end of the socket in the lead adapter cable at an angle to ensure the connector pins do not get bent (Figure 6.4). Push the lead adapter plug into the socket on the lead adapter cable until it clips into place.
  • Page 17 Figure 6.4: Placing the lead adapter plug into the socket on the lead adapter cable. 5. To connect a second lead to the lead adapter repeat the above steps 1 to 4 (see Figure 6.5). Figure 6.5: Placing a second lead adapter into the lead adapter cable. 6.1.2 Connect the lead adapter cable to the lead adapter extension Plug the lead adapter extension into the proximal connector of the lead adapter cable until...

  • Page 18: Clinical Programming - Introduction

    The computer is not physically modified in any way. The CI operates on the Microsoft Windows platform. The CI is supplied with the software necessary for programming Saluda Medical stimulators pre-installed, and no other software should be installed on the device.

  • Page 19: Clinical System Transceiver (Cst)

    This will lead the user into the Clinical Programming Application (CPA) that enables programming of either the Evoke eCLS or CLS. Note: Login password for the CI will be provided by Saluda Medical representatives. Should the CI operator or the CI operator’s organisation wish to change this password it is their responsibility that all potential operators are aware of this password and can easily access it should it be forgotten.

  • Page 20: Connecting The Ci To The Cst And Ecls/Cls

    1. Connect the CST to the CI with the USB connection (see Figure 8.1). Figure 8.1: Connecting the CST to the CI 2. Position the CST near the stimulator and double-click the Evoke Clinical Programming Application (CPA) icon to start the program (see Figure 8.2 for the main screen layout).
  • Page 21 Stimulation sets ECAP Measurement bar graph ECAP Measurement and Electrode Display Window Stimulation Side Current rolling plot (‘Stimulation Settings’ and ‘ECAP Amplitude Control Measurement Settings’ hidden) Text Stimulation Settings (hidden) Input ECAP Stored Active Error Log Display programs program ECAP Measurement Count Settings (hidden) CLS Menu and RF...

  • Page 22: Set Stimulator Time

    Visit Name Connect to dropdown menu Implant button Figure 8.3: Location of the Visit Name dropdown menu and setting button 5. Click on the stimulator serial number that you wish to connect to. 6. The CPA will connect to the stimulator and retrieve any patient data and programs. Note: Depending on the amount of data saved on the device this could take several minutes.

  • Page 23: Retrieve Or Set The Patient Id And Patient Zone

    8.4 Retrieve or set the Patient ID and Patient Zone 8.4.1 For an existing patient 1. On connection to the stimulator the Patient ID and Patient Zone are retrieved and Patient ID Patient field Zone field displayed under the CLS icon (see 2.

  • Page 24: Measure Electrode Impedance

    5. Navigate to the settings page by opening the Navigation Menu and tapping Settings (see Figure 8.6). Select the appropriate Patient Zone (see Figure 8.7). 6. Return to the CLS programming page by opening the Navigation Menu tapping Programming (see Figure 8.6). Figure 8.6: Navigation Menu Patient Zone dropdown menu...

  • Page 25: Set Up Lead Orientation

    Figure 8.8: Impedances displayed on the 24 electrodes and CLS case (#25). 4. Electrodes with a cross through them are high impedance (> 4000 Ω) and may be disconnected. Disconnected electrodes show an impedance of ∞ and cannot be used for stimulation or recording. Note: The CLS case cannot be used for stimulation, and may show as high impedance (>...

  • Page 26: Choose The Stimulation Electrodes Automatically

    Figure 8.9: You can drag the leads up, down or switch sides. 8.7 Choose the stimulation electrodes automatically 1. Stop stimulation if stimulation is running. 2. Change the Electrode Selection Mode icon (see Figure 8.2) until the Automatic Electrode Selection icon is displayed.

  • Page 27: Start And Stop Stimulation

    Figure 8.10: Set defaults buttons in the Stimulation, ECAP Measurement, and Settings menus. 8.8 Start and stop stimulation Touch the Stimulation Settings icon to change the stimulation. The icon will change to show the Electrode Display icon (see Figure 8.11). Changes made to the Stimulation Settings will affect the Stimulation Amplitude Control bar on the right (refer to Figure 8.12 for more details).

  • Page 28: Set Up Ecap Measurement

    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 Measurement and Current rolling plot. 2. Touch the Up arrow to increase stimulation current to the desired level (mA) (Figure 8.12A).
  • Page 29 Graph of ECAP Figure 8.13: Location of ECAP display on the CPA. The ECAP display shows both a single and an averaged ECAP as well as the correlation filter used to measure the Feedback Variable (Figure 8.14). The ECAP display shows the current filter settings and the recommended filter settings, the sampling period, and buttons to zoom in and out of the Y-Scale.

  • Page 30: Set Up Feedback Control (Fc) Therapy

    Figure 8.15: A) ECAP Measurement and Current rolling plot; B) ECAP Measurement Settings menu; C) Location of ECAP Measurement settings icon showing the Electrode Display icon; D) Patient sensitivity graph. 3. Touch ‘Apply’ to set the optimal Processing Offset . The open circle on the graph is the recommended offset (peak of graph), while the black line is the offset setting in use.

  • Page 31: Enable Feedback Control

    Calculated Patient Sensitivity Stimulator ECAP output current measurement axis axis Figure 8.16: The Patient Sensitivity graph – ECAP measurement (μV) versus Current (mA) 4. Enter the calculated value for patient sensitivity in the Measurement and Feedback Settings menu (see Figure 8.15B). 8.11 Enable Feedback Control Once all the settings for the program have been set up it is important to test the effectiveness of the Feedback Control.
  • Page 32 Program Slots Save Slots Figure 8.18: Location of the Program Slots and Save Slots on the CPA. 8.12.1 To add a new program 1. Touch the desired Program Slot (see Figure 8.18) and you will see a number corresponding to that Program slot appear in the box. 2.

  • Page 33: Interleaved Stimulation

    8.12.2 To copy settings from one Program to another 1. Drag the Program number to the desired Program Slot for the new program. Note: You should save the programs to a Save Slot before overwriting a program in case you want to restore the previous one. 8.12.3 To save a Program into the Save Slots You can create a backup of a Program from the stimulator or save a newly created Program for later use in the Save Slots.
  • Page 34 Stimulation Sets Ungroup/ Group Sets Enable/ Disable Set Figure 8.20: Location of controls related to interleaved stimulation in the CPA. 8.13.1 Set up interleaved stimulation To set up multiple Stimulation Sets in a Program: 1. Select a Program, and Stimulation Set A. a.
  • Page 35 Note: Feedback Control will only operate based on the settings in Stimulation Set A (it will vary the current so that the ratio of current between Stimulation Sets remains constant). Figure 8.21: A Program with 4 Stimulation Sets configured at desired levels. Note that the electrode settings from all Stimulation Sets are visible in the background while the active set is displayed as normal.

  • Page 36: Neurophysiological Measurements

    All enabled Stimulation Set A disabled Figure 8.22: (Left) Original current levels with all Stimulation Sets enabled. (Right) Current levels with Stimulation Set A disabled. 8.13.3 Changing the ratio between Stimulation Sets The ratio between Stimulation Sets can be changed, even during stimulation (Figure 8.23): 1.
  • Page 37 8.14.1 Accessing the Neurophysiological Measurement menu The neurophysiological measurement programs can be accessed through the CLS menu by touching the ‘CLS icon’ for additional CLS and eCLS functions, then touching the ‘More…’ field and selecting ‘Show Neurophysiological Measurements’. Neurophysiological Measurement menu Figure 8.24 Location of controls to initiate neurophysiological measurements 8.14.2 Neurophysiological Measurement Menu Perform a test to measure the Chronaxie and...
  • Page 38 8.14.3 Chronaxie and Rheobase Test This program can be used to automatically obtain measures of the Chronaxie and Rheobase of the stimulated neurons.  Rheobase: The minimum current required to elicit neural activation in the spinal cord at infinite pulse width. ...
  • Page 39 a. Touch ‘Resume’ to continue changing current in the same direction. b. If current was increasing touch ‘Next’ to start the current decreasing. c. Touch ‘Cancel’ to turn stimulation off and stop the Chronaxie and Rheobase test. After completion of the test the stimulation settings will return to their previous state. Rheobase and Chronaxie calculation using the obtained data can be made using the Clinical Data Viewer (CDV).
  • Page 40 Figure 8.25 Example starting electrode positions for: A. Fixed Reference recordings; B. Fixed Distance recordings. 6. Touch ‘continue’. 7. Touch the direction icon for the direction that the measurement electrode should move. 8. Start stimulation in open-loop mode and touch continue. 9.
  • Page 41 To perform a Lead Offset Test: 1. Set the electrode configuration with stimulation electrodes on one lead (usually in the middle of the lead), measurement electrodes on the other lead (usually at the top of the lead) and the reference electrode on the Case electrode (E25) or at the end of the lead furthest from the stimulation electrodes.

  • Page 42: Clinical Interface - Settings Guide

    9 Clinical Interface – settings guide 9.1 Stimulation Settings Menu Stimulation Frequency 10 – 1500 Hz (Hz) Pulse Width 20 – 1000 μs Maximum stimulation 1 – 50 mA current Current increment 0.05mA – 4.0mA (depending on the electrode setup) 9.2 Measurement and Feedback Settings Menu Measurement type Disabled, Raw data, Filter(+), Filter (-),...

  • Page 43: Electrode Selection Modes

    9.3 Electrode selection modes You can configure electrodes automatically or manually by touching the Electrode Selection Mode icon when stimulation is turned off. The selection mode toggles between: You select the stimulation electrode and all other electrodes are chosen automatically: ...

  • Page 44: Patient Perception

    Figure 9.1: Current steering: 50:50% on the left and 70:30% on the right. 9.5 Patient Perception During programming you may wish to mark the patient’s perception levels on the CPA. 1. The ‘Threshold’, ‘Comfort’ (C- and C+ for lower and upper bounds of Comfort), and ‘Maximum’...

  • Page 45: Cls Menu

    9.6 CLS Menu Touch the “CLS icon” for additional CLS and eCLS functions. Disconnect Disconnect CPA from stimulator Connect to … Search and connect CPA to stimulator. Implant Run in Demonstration mode. Normal Connect to … operation connected to a simulated (demo) Demo stimulator Run in Experimental mode.

  • Page 46: Navigation Menu

    Touch the ‘More…’ field for the next menu. Show Show buttons to execute neurophysiological Neurophysiological measurement programs in place of the stored Measurements programs display. Allow Enable or disable changing the enablement/disablement of Feedback Control (FC) mode from the EPC. When EPC Mode Change is enabled the FC mode can be changed from the EPC.

  • Page 47: Settings Menu

    Touch the “Settings icon” for additional CPA functions. Navigation Menu Open the Navigation Menu. Stop Stop stimulation Engineering Used by Saluda Medical staff to obtain Information device related information. Set Defaults Set Settings page values to defaults Pulse Shape Biphasic - Positive first, Negative first.

  • Page 48: Error Display

    Patient Zone Set the region or zone for the patient 9.9 Error Display When errors occur, they will be displayed over the ECAP Measurement and Current rolling plot (Figure 9.3). A count of the errors from the error log are also displayed to the right of the Stop button (see Table 9.1 for more information regarding the symbols).

  • Page 49: Operation Of Stimulator When Errors Occur

    A red cross in the CLS icon indicates a safe mode error 1. Use the CPA to reset the CLS out of Safe Mode (see Soft Reset in Section 9.6). 2. Contact Saluda Medical to report the occurrence of the error code displayed. 10 Operation of stimulator when errors occur Refer to Section 0 for error display on the CPA.

  • Page 50: Electrode Disconnected

    Feedback Control is disabled until the ECAP measurement returns. 11 Evoke Pocket Console and Evoke Charger Note: Full details on the use of the Evoke Pocket Console (EPC) and the Evoke Charger are available in the Evoke SCS System User Manual.

  • Page 51: Clinical Studies - Set Treatment Arm

    Treatment Arm mode if no buttons are pressed for six seconds. 12 Evoke Charger Refer to the Evoke SCS System User Manual for instructions on using the Charger. 12.1 Safe Mode Error on Charger If the patient reports that their Charger detects that the CLS is in Safe Mode (Contact Clinician indicator lit) then the CLS cannot be charged normally.

  • Page 52: Patient Id Card

    14 Maintenance of the Evoke CI and Evoke CST 14.1 Maintenance of the Evoke CI Maintenance of the Clinical Interface should be carried out according to instructions in the Surface Pro 4 manual accessible at https://www.microsoft.com/surface/en-...

  • Page 53: Specifications

    : It is important is important to apply the updates as soon as possible as they may contain important safety or security improvements. 14.3 Maintenance of the Evoke CST The CST is not expected to be in direct contact with patients but should still be periodically cleaned.

  • Page 54: Evoke Pocket Console

    Low: -20 °C (-4 °F) High: 60 °C (140 °F) Temperature Limitations 15.3 Evoke Pocket Console Table 15.2: Evoke Pocket Console. Materials ABS Plastic Dimensions 105 mm x 58 mm x 18.5 mm (4.13 in x 2.28 in x 0.73 in) Weight 88 g (3.1 oz)

  • Page 55: Evoke Cls

    32 MB, up to 1 year (Stimulation usage, ECAP amplitude and current statistics) Radio opaque “SME AYY” identifier Where “SME” is Saluda Medical, “A” is the CLS model and YY is the two-digit year of manufacture Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 55 of 61...

  • Page 56: Evoke Ecls

    Charging using inductive coupling with an external coil IP Rating IP22 Storage Low: -10°C (14°F) High: 55°C (131°F) Temperature Limitations 15.7 Evoke 12C Percutaneous Lead Table 15.6: Evoke Percutaneous Lead. Materials Lead body Pellethane Lead ends Pellethane and epoxy Distal electrodes...

  • Page 57: Saluda Medical Evoke System Limited Warranty

    (1) year from the date of implantation of the original lead. 16.3 Externals Saluda Medical warrants that the Evoke Pocket Console (referred to as the EPC) and the Evoke Charger will function within normal tolerances and be free from defects in materials or workmanship within a period of one (1) year from the date of purchase.

  • Page 58: Limitations

    Accident, misuse, abuse, negligence or the patient’s failure to operate the Evoke System according to the labelling and instructions for use provided. c. Unapproved attempts to repair, maintain or modify the Evoke System by the patient or any unauthorized third party.

  • Page 59: Glossary And Symbols

    An electrical contact that may be employed to deliver therapeutic current, measure neural responses or control closed-loop stimulation. A remote controller that allows the patient to adjust the therapy output Evoke Pocket Console from the CLS/eCLS (EPC) Evoked Compound Action The sum of electrical signals elicited by a stimulus from multiple nerve fibers.

  • Page 60: Symbols

    Date of manufacture (YYYY = year, MM = month, DD = day) YYYY-MM-DD Do not dispose of this product in the unsorted municipal waste stream – return to Saluda Medical for disposal Type BF applied part Non-ionizing electromagnetic radiation Do not use if package is damaged...

  • Page 61: Contact Us

    18 Contact us Most questions you have about the Evoke Closed Loop Stimulator and its accessories can be answered by reading this manual or looking at our website, www.saludamedical.com and/or www.saludamedical.com/manuals. If you have any further questions, please contact your Saluda Medical field clinical engineer (FCE).

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