SALUDA MEDICAL Evoke Clinical Manual Download

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Document Reference: ENG-UMAN-000731

Revision: 5.00

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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.

Summary of Contents for Evoke

Page 1: ...al 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...

Page 2: ...IME 22 8 4 RETRIEVE OR SET THE PATIENT ID AND PATIENT ZONE 23 8 5 MEASURE ELECTRODE IMPEDANCE 24 8 6 SET UP LEAD ORIENTATION 25 8 7 CHOOSE THE STIMULATION ELECTRODES AUTOMATICALLY 26 8 8 START AND STO...

Page 3: ...GLOSSARY AND SYMBOLS 59 17 1 GLOSSARY 59 17 2 SYMBOLS 60 18 CONTACT US 61 Trademarks Saluda Evoke and the Saluda Medical logo are either trademarks or registered trademarks of Saluda Medical Pty Ltd C...

Page 4: ...Closed Loop Stimulator eCLS Catalogue Number 0020 2020 During the trial stimulation period the leads are connected to the Evoke External Closed Loop Stimulator eCLS The eCLS is an external stimulator...

Page 5: ...stimulator 2 Indications 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 including unilateral or bilateral p...

Page 6: ...may also occur to the CLS Interference with implanted cardiac devices The Evoke System may interfere with other implanted stimulators with sensing capabilities such as demand type pacemakers or cardi...

Page 7: ...ed without using electric current near the implanted stimulator or leads 4 2 Precautions Physician training Implanting physicians should be trained in spinal cord stimulation SCS procedures Physicians...

Page 8: ...Patients may experience redness or irritation at the implant site in which case they should contact their physician to check the wound for infection or adverse reaction to the implanted materials Stim...

Page 9: ...tients should be advised to not plug the Charger into outlets that are in humid environments such as a bathroom or near water If patients need to clean their accessories refer them to the Evoke Instru...

Page 10: ...re installed and affect the delivery of therapy for patients 4 2 4 Modification of the programming software Do not attempt to modify the Clinical Programming Application CPA software which comes prein...

Page 11: ...ll charged so it can be used in clinical environments where plug sockets are not readily available Always have a spare charged CI available in case of malfunction 4 3 Potential Risks Every surgery inv...

Page 12: ...pping using intraoperative patient feedback Following lead placement based on required anatomical location the surgeon connects the leads to the lead adapters and the lead adapters to the lead adapter...

Page 13: ...sconnect the eCLS from the lead adapter extension 6 The surgeon then disconnects the lead adapter from the lead 5 1 2 2 Paresthesia mapping This section is to be completed by the programming clinician...

Page 14: ...S header when satisfied that there is a proper connection o Always check the impedance before tightening CLS header set screw 6 Post Operative Procedures The stimulator eCLS or CLS can be programmed w...

Page 15: ...p 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 6 2 Pushing lead into s...

Page 16: ...ne 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 sock...

Page 17: ...dapter 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 you fe...

Page 18: ...ogramming Introduction 7 1 Clinical Interface CI The CI is a Microsoft Surface Pro 4 tablet computer Figure 7 1 shows basic physical configuration Full specifications for the tablet computer are avail...

Page 19: ...Transceiver CST The CST is a radio telemetry device that enables communication between the CI and the stimulator eCLS or CLS Commands generated through the CPA loaded on the CI are sent to the stimula...

Page 20: ...download data from the eCLS or CLS communication must first be established The CST connects to the CI to communicate using a radio signal transmitted to the eCLS or CLS 1 Connect the CST to the CI wit...

Page 21: ...ee Figure 8 3 Stimulation Settings hidden ECAP Measurement bar graph Side Bar Electrode Display Window Stimulation Settings and ECAP Measurement Settings hidden Stimulation Amplitude Control ECAP Meas...

Page 22: ...log files from the stimulator If any logs cannot be downloaded an error message will be displayed on the ECAP Measurement and Current rolling plot see Section 0 To download the logs manually such as...

Page 23: ...Patient ID and Zone underneath 8 4 2 For a new patient 1 For a new patient touch the Patient ID box under the CLS icon see 2 Figure 8 4 3 Delete any existing text and enter the new Patient ID 4 Touch...

Page 24: ...e Figure 8 6 Figure 8 6 Navigation Menu Figure 8 7 Settings Menu with Patient Zone dropdown menu highlighted 8 5 Measure electrode impedance Measure the electrode impedance to determine if all connect...

Page 25: ...d care should be taken when programming Caution If the electrodes show an open circuit disconnected Wipe any blood or fluid off the lead connection contacts If the system is fully implanted high imped...

Page 26: ...ctrode again to cycle through electrode configurations Tripolar 1 lead Bipolar 1 lead Tripolar 2 leads Bipolar 2 leads 5 The CPA will automatically select the stimulation return measurement and refere...

Page 27: ...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...

Page 28: ...the current scale is shown on the right side Figure 8 12D The scale will extend to the Maximum current set Figure 8 12B A Up arrow B Maximum current C Current scale D Current increment scale E Desire...

Page 29: ...s are in order Sampling Delay Processing Offset number of samples filter frequency and number of filter samples 1 Touch the ECAP Measurement Settings icon to open the Measurement and Feedback Settings...

Page 30: ...ine is the frequency setting in use 5 The ECAP Measurement and Current rolling plot Figure 8 15A displays the ECAP measurement top and current bottom over time 8 10 Set up Feedback Control FC therapy...

Page 31: ...FC on see ECAP Measurement bar in Figure 8 2 Figure 8 17 ECAP Measurement and Current rolling plot with FC turned on 3 With FC enabled the rolling plot will now display with an orange background and t...

Page 32: ...he CPA has not been run on the stimulator such as a new program or one that has been modified it will be shown in red in the corresponding Program Slot Once a program has been run its number will be s...

Page 33: ...ot be available on any other CI 8 12 4 To restore a Program from the Save Slots To restore a saved program into the stimulator 1 Touch the desired Save Slot and choose Restore a You may restore all th...

Page 34: ...rogram with the desired stimulation settings see Sections 8 7 to 8 8 b Frequency Maximum Current and Current Increment are equal across Stimulation Sets while Pulse Width may be set independently Note...

Page 35: ...ctive set is displayed as normal 8 13 2 Enable Disable a Stimulation Set in a Program To enable disable a Stimulation Set in a Program 1 Select the Stimulation Set you want to enable disable 2 Press t...

Page 36: ...level 3 Group the Stimulation Sets and continue stimulation as normal Original ratios Stimulation Set C selected Stimulation Set C ratio lowered Figure 8 23 Left A Program with 4 Stimulation Sets in...

Page 37: ...ophysiological measurements 8 14 2 Neurophysiological Measurement Menu Perform a Chronaxie and Rheobase Test Perform a test to measure the Chronaxie and Rheobase of the stimulated neurons See Section...

Page 38: ...m charge factor default is 0 8 and touch Continue 4 Use the sliding scale to input the Current ramp speed default 20 steps and touch Continue 5 Touch Yes if you wish to set the program parameters to t...

Page 39: ...a constant current level To perform a Conduction Velocity test 1 Choose the stimulation electrode configuration and settings that you wish test 2 Touch Conduction Velocity from the neurophysiological...

Page 40: ...l is strong Then reduce the current until the patient reports it has returned to a comfortable level 10 Touch Continue to begin test After completion of the test the electrode configuration will need...

Page 41: ...cted or shorted electrodes 4 Start stimulation in open loop mode and touch Continue 5 Touch the direction icon for the direction that the measurement electrode should move usually down from the top of...

Page 42: ...ings Menu Measurement type Disabled Raw data Filter Filter Amplitude Sampling period 122 10009 s 2 164 samples Processing offset 0 3662 s 0 60 samples Processing Offset graph ECAP measurement vs proce...

Page 43: ...equired and all the other electrodes remain the same Note Can be changed during stimulation if FC is off Manual electrode selection You select the electrode you wish to change and the electrode will t...

Page 44: ...rt and Maximum buttons Figure 9 2 can be used to mark when the stimulation is first felt by the patient when it is comfortable and when it is very strong respectively The levels will be indicated by h...

Page 45: ...o this SS Apply measurement to the selected stimulation set Clear Stim Set Clear the selected stimulation set from the program Clear Program Clear the selected program from the stimulator Lead Configu...

Page 46: ...stimulator clear Safe Mode errors clear programs and reconnect Log Setup Set up therapy log settings Size Normal 1 5 MB or Research 13 MB Duration 1 day to 1 year Erase Space to Store Data for Configu...

Page 47: ...ve first Interphase Gap 20 500 s Min Inter Stimulus Interval Interval of stimulation set pulses Auto minimum permitted ISI 1400 50000 s Max Stimulation Voltage 7 5 15 V Max Stimulation Ramp Rate Only...

Page 48: ...ds to errors see Section 10 Figure 9 3 Error display and error counts on the CPA screen Table 9 1 Error count symbol information Note that a means log was not downloaded or that an error occurred duri...

Page 49: ...nt exceeds the Maximum Stimulation Voltage see Section 9 8 This may also occur with disconnected stimulation electrodes When OOC is indicated the patient may not increase intensity with the EPC stimul...

Page 50: ...ording electrodes are disconnected then stimulation stops When Feedback Control is enabled if the stimulator detects a potential problem with the ECAP measurement then stimulation stops and Feedback C...

Page 51: ...ators glow steadily 3 To change the treatment arm Press to change to Arm A Press to change to Arm B 4 Press to set the treatment arm to that selected and exit the Set Treatment Arm mode Note The EPC w...

Page 52: ...Updating the Evoke CI Software The CI contains software Kaseya that automatically checks if there are any updates that can be downloaded and applied to the CI The CI must be connected to the internet...

Page 53: ...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 The CST can be clean...

Page 54: ...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 Stimulator range Up to 1 0 m 1 1 yd Battery Battery type 2 x AAA size 1 5V 1200 mAh or greater alkaline batteries Battery life...

Page 55: ...parameters Current 0 mA 50 mA 20mA at 750 Pulse Width 20 s 1000 s Frequency 10 Hz 1500 Hz Radio frequency communication MICS band 403 MHz Range 1 0 m 3 3 ft Battery Battery type 200 mAh Li Ion rechar...

Page 56: ...ion 15 5 with the exception of the following Electrodes 24 Port 1 electrodes 1 24 Charging Charging using inductive coupling with an external coil IP Rating IP22 Storage Temperature Limitations Low 10...

Page 57: ...efects in materials or workmanship within a period of one 1 year starting from their date of implantation This limited warranty does not apply to the surgical accessories used with the lead Should a l...

Page 58: ...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 16 5 Limit...

Page 59: ...lator eCLS The eCLS is a non implantable device with the same functionalities as the CLS Feedback Control FC The automatic adjustment of stimulation output in response to a measured ECAP Interphase Ga...

Page 60: ...ruction for Use at www saludamedical com manuals Temperature limitation F and C Manufacturer YYYY MM DD Date of manufacture YYYY year MM month DD day Do not dispose of this product in the unsorted mun...

Page 61: ...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 Alternativ...

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