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SALUDA MEDICAL Evoke Clinical Manual

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Evoke™ SCS System Clinical Manual
Use of the Evoke Clinical Interface (CI) and software (CPA) with the
Evoke Clinical System Transceiver (CST) for programming the Evoke
SCS System
Document Reference: CLIN-UMAN-002424
Revision: 12.00

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  • Page 1 Evoke™ SCS System Clinical Manual Use of the Evoke Clinical Interface (CI) and software (CPA) with the Evoke Clinical System Transceiver (CST) for programming the Evoke SCS System Document Reference: CLIN-UMAN-002424 Revision: 12.00...

  • Page 2: Table Of Contents

    Evoke™ Clinical Manual Table of Contents DESCRIPTION ......................4 (FC) ................. 4 HE CONCEPT OF EEDBACK ONTROL (CLS) ................4 VOKE LOSED TIMULATOR CLS) ............4 VOKE XTERNAL LOSED TIMULATOR 12C P , 60 ............5 VOKE ERCUTANEOUS CM AND...
  • Page 3 • System warnings and precautions • Other system component device specifications and package contents Refer to the Evoke SCS System User Manual for full details on the use of the Evoke Pocket Console (EPC) and Evoke Charger. Refer to the Evoke SCS System MRI Guidelines for information on the safe use of the Evoke System in the MRI environment.

  • Page 4: Description

    Feedback Control (FC). 1.1 The concept of Feedback Control (FC) Figure 1.1, below, explains the concept of FC in the Evoke SCS System using the measurement of Evoked Compound Action Potentials (ECAPs). Following a stimulation impulse, the magnitude of the ECAP generated in the spinal cord from that stimulus is recorded.

  • Page 5: Evoke 12C Percutaneous Lead Kit, 60Cm And 90Cm

    Ref No. 1006 - EU/4006 - UK/5006 - AU The Evoke Charger allows you to recharge the battery in a CLS (or eCLS, if applicable). The Charger coil (attached to the Charger) is placed over the CLS and charge is transferred to the CLS through thin clothing and the skin.

  • Page 6: Package Contents

    Contents: One (1) Clinical System Transceiver (CST) 3 Indication for use The Saluda Medical Evoke SCS System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs. 4 Contraindications The Evoke System should not be used in patients who: •...
  • Page 7 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 8: Introduction

    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 9: Evoke 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 and cannot be changed. All potential CI operators should be made aware of this password.
  • Page 10 Evoke™ Clinical Manual Figure 7.1: Connecting the CST to the CI. 2. Position the CST near the stimulator and double-click the Evoke Clinical Programing Application (CPA) icon to start the CPA (see Figure 7.2 for the main screen layout). Note: The CST can link with the stimulator within a 1.0 m (3.3 ft) radius.
  • Page 11 Evoke™ Clinical Manual Stimulation sets ECAP Measurement bar ECAP Measurement and Side Electrode Display Window Stimulation Current rolling plot (‘Stimulation Settings’ and ‘ECAP Amplitude Control Measurement Settings’ hidden) Stimulation Settings Text Input (hidden) ECAP Stored Active Error Log Display programs...

  • Page 12: Set Stimulator Time

    Evoke™ Clinical Manual 3. Choose the appropriate Visit Name from the dropdown menu (see Figure 7.3). 4. Touch Connect to Implant to search for nearby stimulators (see Figure 7.3). Visit Name Connect to dropdown menu Implant button Figure 7.3: Location of the Visit Name dropdown menu and Connect to Implant button 5.

  • Page 13: Retrieve Or Set The Patient Id And Patient Zone

    Evoke™ Clinical Manual Note: If out of sync, a red ‘clock’ icon will be displayed in the CLS icon window and the time error between CI and stimulator is displayed in brackets in the CLS menu. Note: Ensure that the time and date on the CI are correct (top left corner of CPA screen, Figure 7.2).

  • Page 14: Measure Electrode Impedance

    Evoke™ Clinical Manual Figure 7.6: Navigation Menu Patient Zone dropdown menu Figure 7.7: Settings Menu with Patient Zone dropdown menu highlighted 7.4 Measure electrode impedance Measure the electrode impedance to determine if all connections are intact between leads, any lead adapters, and the stimulator.

  • Page 15: Set Up Lead Orientation

    Evoke™ Clinical Manual Figure 7.8: Impedances displayed on the 24 electrodes and CLS case (#25). 3. 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.

  • Page 16: Programming Overview

    Evoke™ Clinical Manual Figure 7.9: You can drag the leads up, down or switch sides. 7.6 Programming overview 1. Test stimulation from several electrodes (see Section 7.7 and 7.8) and ask the patient to report where they feel paresthesia. 2. Determine the stimulation electrodes that give the best paresthesia coverage of the patient’s painful anatomy.

  • Page 17: Start And Stop Stimulation

    Evoke™ Clinical Manual 5. The CPA will automatically select the stimulation , return measurement and reference electrodes for you. • You may steer the current between stimulation electrodes (see Section 8.4). • You can also manually change the electrode configuration (see Section 8.3).
  • Page 18 Evoke™ Clinical Manual Start Stimulation Figure 7.11: Location of the Stimulation Settings Menu and Start Stimulation arrow on the CPA. 1. Touch the Start Stimulation arrow (see Figure 7.11). 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.

  • Page 19: Set Up Ecap Measurement

    Evoke™ Clinical Manual 7.8.1 Stop 1. Touch the Stop button to stop stimulation at any time. 7.9 Set up ECAP measurement The stimulator records the ECAP signal and displays a graph of the ECAP on the programming screen (Figure 7.13). ECAP measurement is only possible when the stimulation is running and a clear signal is visible.

  • Page 20: Set Up Feedback Control (Fc) Therapy

    Evoke™ Clinical Manual Figure 7.15: A) ECAP Measurement and Current rolling plot; B) ECAP Measurement Settings menu; C) ECAP Measurement settings icon; D) Patient sensitivity graph. 1. Touch the ECAP Measurement Settings icon to open the ‘Measurement and Feedback Settings’ menu (Figure 7.15B). The icon will change to show the Electrode Display icon (Figure 7.15C).

  • Page 21: Enable Feedback Control

    Evoke™ Clinical Manual Calculated Patient Sensitivity ECAP Stimulator measurement output current axis axis Figure 7.16: 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 7.15).
  • Page 22 Evoke™ Clinical Manual Program Slots Save Slots Figure 7.18: Location of the Program Slots and Save Slots on the CPA. 7.12.1 To add a new Program 1. Touch the desired Program Slot (see Figure 7.18); you will see a number corresponding to that Program Slot appear in the box.
  • Page 23 Evoke™ Clinical Manual Note: You should save the Programs to a Save Slot before overwriting a Program in case you want to restore the previous one. 7.12.3 To save a Program into the Save Slots After the CPA Connects or Disconnects from a stimulator, all the Programs in the Program Slots are saved to a Save Slot and also saved as a Program file on the CI.

  • Page 24: Interleaved Stimulation

    Evoke™ Clinical Manual 7.12.5 To clear the Program from a Save Slot 1. Touch the desired Save Slot and choose Clear. Note: Clearing the Save Slot does not delete the Program file saved on the CI. 7.13 Interleaved Stimulation A Program may contain several interleaved Stimulation Sets, targeting several areas of pain.
  • Page 25 Evoke™ Clinical Manual 4. Select a Stimulation Set and increase current to the patient preferred level, then stop stimulation. 5. Repeat Step 4 for each remaining Stimulation Set in the Program until all have been set to the patient preferred level (Figure 7.21).
  • Page 26 Evoke™ Clinical Manual All enabled Stimulation Set A disabled Figure 7.22: (Left) Original current levels with all Stimulation Sets enabled. (Right) Current levels with Stimulation Set A disabled. 7.13.3 Changing the ratio between Stimulation Sets The ratio between Stimulation Sets can be changed, even during stimulation (Figure 7.23): 1.

  • Page 27: Clinical Interface - Settings Guide

    Evoke™ Clinical Manual 8 Clinical Interface – Settings Guide 8.1 Stimulation Settings Menu Stimulation Frequency 10 – 1500 Hz (Hz) Pulse Width 20 – 1000 μs Maximum stimulation 1 – 50 mA current Current increment 0.05 mA – 4.0 mA (depending on the electrode setup) 8.2 Measurement and Feedback Settings Menu...

  • Page 28: Electrode Selection Modes

    Evoke™ Clinical Manual 8.3 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 29: Patient Perception

    Evoke™ Clinical Manual Figure 8.1: Current steering: 50:50 (%) on the left and 70:30 (%) on the right. 8.5 Patient perception During programming you may wish to mark the patient’s perception levels on the CPA. 1. The ‘Threshold’ (T), ‘Comfort’ (C- and C+ for lower and upper bounds of Comfort, respectively) and ‘Maximum’...

  • Page 30: Patient Survey

    Survey. 2. The patient must give consent to collect the survey information and for information to be backed-up remotely on Saluda Medical servers. 3. Read the consent language to the patient and record the answer on the survey page (Figure 8.3).

  • Page 31: Cls Menu

    Evoke™ Clinical Manual 8.7 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)
  • Page 32 Evoke™ Clinical Manual Enable or disable the ability to change the Feedback Control (FC) mode with the EPC. When EPC Mode Change is Enabled the FC mode can be changed from the EPC. When EPC Mode Change is Disabled the FC mode cannot be changed from the EPC.

  • Page 33: Navigation Menu

    Tap the Navigation Menu icon and choose Settings for additional settings. 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...

  • Page 34: Alert And Error Display

    Evoke™ Clinical Manual Restore devices to default factory settings. Factory Reset For use by Saluda Medical Field Clinical Engineer (FCE). Reset of Last Resort For use by FCE. Stop all CLS functions to conserve battery. Enter Stock Mode Use the Charger to leave stock mode.

  • Page 35: Intra-Operative Programming With The Ci

    (see Evoke SCS System User Manual). 1. Use the CPA to reset the CLS or eCLS out of Safe Mode (see Soft Reset in Section 8.7). 2. Contact Saluda Medical to report the occurrence of the error code displayed. 9 Intra-operative programming with the CI...

  • Page 36: Confirmation Of Optimal Lead Placement

    (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 37: Confirmation Of Proper Cls Connection

    Evoke™ Clinical Manual 1. Connect the CI to the eCLS. 2. Check electrode impedance using the CI to ensure the leads are connected properly. • If electrode impedance is greater than 4000Ω check all the connections. • Check impedance after each reconnection of the proximal connector to the lead adapter 3.

  • Page 38: Post-Operative Programming Procedures

    Evoke™ Clinical Manual the lead into the ports in the header of the CLS either directly or via an extension and places the CLS partially into the CLS pocket. Programming clinician tasks: 1. Connect the CI to the CLS via the radio link (see Section 7.1).
  • Page 39 Evoke™ Clinical Manual Figure 10.2: Pushing lead into slot. 3. Place the top cover of the lead adapter over the lead, with the open side of the top cover aligned with the lead adapter plug. Slide the top cover all the way onto the lead adapter until the notch on the top cover clips into place (refer to Figure 10.3).
  • Page 40 Evoke™ Clinical Manual Figure 10.3: 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 10.4).

  • Page 41: Connect The Lead Adapter Cable To The Lead Adapter Extension

    Evoke™ Clinical Manual Note: If you are reconnecting leads to an eCLS that has already been programmed, ensure that the lead and lead adapter are reinserted into the same ports as used during previous programming. Figure 10.4: Placing the lead adapter plug into the socket on the lead adapter cable.

  • Page 42: Operation Of Stimulator When Errors Occur

    Evoke™ Clinical Manual 11 Operation of stimulator when errors occur Refer to Section 8.10 for error display on the CPA. 11.1 Out of Compliance Out of Compliance (OOC) occurs when the voltage requirement exceeds the Maximum Stimulation Voltage (see Section 8.9). This may also occur with disconnected stimulation electrodes.

  • Page 43: Evoke Pocket Console And Evoke Charger

    Evoke™ Clinical Manual 12 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. 12.1 Pair EPC to stimulator To enable the EPC to be used with an eCLS or CLS it must first be paired with that stimulator.

  • Page 44: Patient Education And Id Card

    Evoke™ Clinical Manual 13 Patient education and ID card Educate the patient on the use of their EPC and Charger (if applicable) using the Evoke SCS System User Manual. Every CLS is supplied with a Patient ID Card for the surgeon to complete. The surgeon will tick the appropriate boxes on the Patient ID card to indicate if the configuration of the implanted system allows the patient to undergo a MRI scan under prescribed conditions.

  • Page 45: Troubleshooting

    Programming software Icon may have been moved Using the CI search function, locate and (CPA) icon is not or deleted. select the 'Evoke Clinical Programming visible. Application'. The program should start. If this procedure fails, please call your Saluda Representative.
  • Page 46 Evoke™ Clinical Manual Issue Possible Explanation Corrective Action Telemetry may be disrupted. Move CST closer to device. Ensure no EMI from other devices. Rolling plot lacks data System may be busy. Wait for condition to clear or re-start points and appears software.
  • Page 47 Evoke™ Clinical Manual Issue Possible Explanation Corrective Action ERT Clipping causes Recording Electrode is Check electrode connectivity with an stimulation to stop. disconnected. impedance check. Input to amplifier is too Switch to Low Gain Mode. large. Check the impedance and the connections to the stimulator if using an eCLS.

  • Page 48: Technical Specifications

    Evoke™ Clinical Manual 17 Technical Specifications 17.1 Device Specifications Refer to the Evoke SCS System User Manual and Evoke SCS System Surgical Guide for device specifications for additional components of the Evoke SCS System. 17.1.1 Evoke CI specifications Full specifications for the Clinical Interface can be found in the Surface Pro manual accessible at https://support.microsoft.com/en-gb/hub/4295210/surface-pro-help.

  • Page 49: Wireless Communication

    17.2.2 Wireless Security The Evoke SCS System has a communication range of 1 metre (3.3 feet). To enable the CST/EPC to communicate with an eCLS or CLS, it must first be paired with that stimulator. The CST/EPC may communicate with only one CLS or eCLS at a time. The stimulator will not respond to any communication that does not come from a paired device.

  • Page 50: Electromagnetic Interference

    Table 17.2: Electromagnetic emissions The Evoke SCS System is intended for use in the electromagnetic environment specified below. The patient, doctor or any other user of Evoke SCS System should ensure that it is used in such an environment. Electromagnetic environment –...
  • Page 51 Table 17.3: Electromagnetic immunity – electrostatic discharge and mains power The Evoke SCS System is intended for use in the electromagnetic environment specified below. The patient, doctor or any other user of Evoke SCS System should ensure that it is used in such an environment.
  • Page 52 Table 17.4: Electromagnetic immunity – radio frequency The Evoke SCS System is intended for use in the electromagnetic environment specified below. The doctor or the patient should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the Evoke SCS System, including the cable, than the recommended separation distance stated below .

  • Page 53: Glossary And Symbols

    A remote controller that allows the patient to Evoke Pocket Console (EPC) adjust the therapy output from the CLS/eCLS Evoked Compound Action Potential The sum of electrical signals elicited by a stimulus...

  • Page 54: Symbols

    Do not dispose of this product in the unsorted municipal waste stream – return to Saluda Medical for disposal Non-ionizing electromagnetic radiation Do not use if package is damaged MR Conditional: Refer to Evoke SCS System MRI Guidelines at http://www.saludamedical.com/manuals Contents Class II Medical Electrical Equipment...

  • Page 55: Regulatory Statements

    19 Regulatory Statements Saluda Medical declares that the Evoke SCS System is in conformity with the essential requirements of Directive 90/385/EEC on Active Implantable Medical Devices. Hereby, Saluda Medical declares that this device is in compliance with Directive 2014/53/EU.

  • Page 56: Contact Us

    Evoke™ Clinical Manual 20 Contact us Most questions you have about programming the Evoke Closed Loop Stimulator and Evoke External Closed Loop Stimulator 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 representative.

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