SALUDA MEDICAL Evoke SCS System User manual

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Evoke™ SCS System Surgical Guide
Instructions for the use and implantation of the Evoke™ SCS System
CAUTION – Investigational Device.
Limited by Federal (or United States) law to investigational use.

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Table of Contents
1DESCRIPTION ............................................................................................................ 4
2INTENDED USE .......................................................................................................... 5
3CONTRAINDICATIONS ............................................................................................... 5
4SAFETY INFORMATION.............................................................................................. 6
WARNINGS .....................................................................................................................6
PRECAUTIONS ..................................................................................................................8
POTENTIAL RISKS............................................................................................................10
5PERCUTANEOUS LEAD IMPLANT PROCEDURE .......................................................... 12
OVERVIEW ....................................................................................................................12
PERCUTANEOUS LEAD PLACEMENT ....................................................................................12
6ANCHOR THE LEAD.................................................................................................. 15
POSITION THE ANCHOR ....................................................................................................15
SECURE THE ANCHOR.......................................................................................................15
CREATE A STRAIN RELIEF LOOP IN THE LEAD ..........................................................................17
7LEAD TUNNELING AND CLS IMPLANT PROCEDURE................................................... 17
LOCATE AND CREATE A POCKET FOR THE CLS........................................................................17
TUNNEL THE LEAD PROXIMAL CONNECTORS AND CONNECT TO THE CLS .....................................17
ANCHOR THE CLS, CLOSE AND DRESS THE INCISIONS ..............................................................21
POST-OPERATIVE PROCEDURES.........................................................................................21
8TRIAL WITH A TEMPORARY PERCUTANEOUS LEAD .................................................. 22
REMOVE THE STYLET AND EPIDURAL NEEDLE.........................................................................22
ANCHOR THE LEAD,CLOSE AND DRESS THE INCISIONS .............................................................22
POST-OPERATIVE PROCEDURES.........................................................................................22
REMOVING A PERCUTANEOUS LEAD AT THE END OF A TRIAL ...................................................22
9REVISION, REPLACEMENT AND EXPLANT SURGERY.................................................. 22
OPEN THE COMPONENT SITES............................................................................................23
PERCUTANEOUS LEADS ....................................................................................................23
CLS .............................................................................................................................23
10 INTRA-OPERATIVE TESTING ..................................................................................... 24

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CONNECT THE LEAD TO THE LEAD ADAPTER.......................................................................24
CONNECT THE LEAD ADAPTER CABLE TO THE LEAD ADAPTER EXTENSION..................................26
CONNECT THE LEAD ADAPTER EXTENSION TO THE ECLS.......................................................26
CONFIRM OPTIMAL LEAD PLACEMENT..............................................................................27
DISCONNECTING THE LEAD ADAPTER FROM THE LEAD ADAPTER CABLE....................................28
DISCONNECT THE LEAD FROM THE LEAD ADAPTER ..............................................................29
11 STERILIZATION ........................................................................................................ 30
12 PATIENT ID CARD .................................................................................................... 30
13 MAINTENANCE OF THE EVOKE™ ECLS...................................................................... 30
14 PACKAGE CONTENTS............................................................................................... 31
15 SPECIFICATION........................................................................................................ 33
EVOKE™CLS .............................................................................................................33
EVOKE™ECLS ...........................................................................................................34
EVOKE™12C PERCUTANEOUS LEAD (INCLUDES TRIAL LEADS)..............................................35
SURGICAL ACCESSORIES ...............................................................................................35
EVOKE™CI SPECIFICATIONS ..........................................................................................37
EVOKE™CST SPECIFICATIONS .......................................................................................37
16 GLOSSARY AND SYMBOLS ....................................................................................... 38
GLOSSARY .................................................................................................................38
SYMBOLS...................................................................................................................39
17 CONTACT US ........................................................................................................... 40
Trademarks
Saluda, Evoke™ and the Saluda logo are 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.
Copyright © 2017 Saluda Medical Pty Ltd, Sydney, Australia. All rights reserved.

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1Description
The 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
subjects neural response during physiological changes and movement by automatically
adjusting the level of stimulation current required to meet the subject’s requested target
level.
The Evoke™ System may be used in conjunction with other pain management therapies, as
determined by the physician.
The Evoke™ System comprises several key components to deliver the therapy.
Table 1.1: Description of Evoke™ System Components
Name: Evoke™ Closed Loop Stimulator (CLS)
Ref No.: 0002
The Evoke™ Closed Loop Stimulator (CLS) is a totally implanted spinal cord stimulator that
connects to the leads and is implanted under the skin for long-term therapy. The CLS
delivers stimulation through the leads and measures the neural response to stimulation.
Name: Evoke™ External Closed Loop Stimulator (eCLS)
Ref No.:0020
During the trial stimulation period, the leads are connected to the Evoke™ External Closed
Loop Stimulator (eCLS). The eCLS is an external stimulator worn during the trial
stimulation period. The eCLS delivers stimulation through the leads and measures the
neural response to stimulation.
Name: Evoke™ 12C Percutaneous Leads
Ref No.:
0008, 0026 (permanent lead length 60 cm)
0016 (trial lead length 60 cm)
0009, 0027 (permanent lead length 90 cm)
0017 (trial lead length 90 cm)
The Evoke™ 12C Percutaneous Leads are placed in the epidural space overlying the spinal
cord and are connected to an eCLS for a trial stimulation period or to a CLS for long-term
therapy.
One or two leads with 12 electrodes on each lead are implanted.
Name: Evoke™ Lead Adapter Kit
Ref No.:0028
The Evoke™ Lead Adapter allows connection between the eCLS and the implanted leads.
Name: Evoke™ Clinical Interface (CI)
Ref No.:0024
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.

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Name: Clinical System Transceiver (CST)
Ref No.:0004
The Clinical System Transceiver (CST) is a plug in device that enables exchange of
information wirelessly between the CI and the stimulator.
Name: Evoke™ Tunneling Tool Kit
Ref No.: 0012
The Evoke™ Tunneling Tool allows the subcutaneous threading of leads and/or extensions
either to an exit incision for the trial stimulation period or to the CLS.
Name: Evoke™ Spares Kit
Ref No.: 0015
The Evoke™ Spares Kit contains all items from the permanent lead kits except for the lead
itself, plus a CLS port plug and torque wrench.
Name: Epidural Needle 6.5” Kit
Ref No. 0014
The 6.5” Epidural Needle Kit is an optional extra long needle for larger patients in whom
the regular 4.5” needle supplied with the lead kits is too short to reach the epidural space.
2Intended 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 pain associated
with the following: failed back surgery syndrome, intractable low back pain and leg pain.
3Contraindications
The Evoke™ System should not be used in patients who:
•Do not receive effective pain relief during trial stimulation
•Are unable to operate the system
•Are unsuitable surgical candidates

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4Safety Information
Patients must be advised of the following warnings and precautions (sections 4.1 and 4.2):
Warnings
Diathermy
•Patients implanted with the Evoke™ System should not be subjected to shortwave,
microwave and/or therapeutic ultrasound diathermy.
•Diathermy generates energy that may cause heating at the lead site resulting in
damage to the CLS, tissue damage, severe injury or death.
Magnetic Resonance Imaging (MRI)
•As the Evoke™ System has not been tested for MRI compatibility, it is considered
MRI unsafe. 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 currents through the leads and stimulator leading to
unintended stimulation, such as tingling, shocking, or jolting.
CT Scans
•Patients implanted with the Evoke™ System may experience a momentary increase
in stimulation when receiving a CT scan. Some patients have described this as
uncomfortable stimulation, jolting or a shocking sensation.
•Prior to a patient undergoing a CT scan, turn the neurostimulator off.
Electrosurgery
•Patients implanted with the Evoke™ System should not be subjected to
electrosurgical techniques, such as electrocautery, in close proximity to the Evoke™
System components.
oElectrosurgical devices generate energy that may cause tissue damage at the
lead site and result in severe injury.
oDamage 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 cardioverter defibrillators.
•The effects of implanted stimulation devices on the Evoke™ System is unknown.
Stimulator damage
•If the CLS case is ruptured or pierced, then patient tissue may be exposed to battery
chemicals, which could lead to burns or tissue damage.
oDo not implant the CLS if the case is damaged.

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Electromagnetic interference
•Strong electromagnetic fields may turn the stimulator off, cause uncomfortable or
jolting stimulation or affect communication with the EPC.
•Patients should be advised to avoid or turn stimulation off around:
oSecurity screeners such as those used at of department stores, public
buildings, and airports – patients should present their implantable device ID
card and request to go around the screener; but if they are required to go
through the screener they should turn stimulation off.
oPower lines or power generators.
oElectric steel furnaces and arc welders.
oLarge, magnetized stereo speakers.
oTag deactivators such as those found in retail stores and libraries.
Heat due to charging
•During charging, the Charger and/or CLS may become warm.
•Patients should not charge while sleeping or with the charging coil in contact with
their skin for prolonged periods as this may result in heating that can cause redness,
skin irritation or a burn.
•If patients experience pain or discomfort, they should cease charging and contact
their clinician.
Notification of an implanted stimulator prior to any other surgical procedures
•Some surgical procedures that use electrical current could affect the patient’s
implanted stimulator and leads, cause serious injury, and may damage the stimulator
•Patients should be advised to inform their clinician prior to any procedure that they
have an implanted stimulator so the procedure can be conducted without using
electric current near the implanted stimulator or leads.
Uncomfortable changes to the stimulation strength due to movement
•Any changes in posture may cause an uncomfortable change or a painful increase in
the stimulation strength patients feel.
•Patients should turn down the stimulation strength or turn off the stimulation before
making posture changes.
The Evoke™ System has not been tested for use in patients who are pregnant or
nursing.
The Evoke™ System has not been tested for use in patients under 18 years old.

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Precautions
Physician training
•Implanting physicians should be trained in SCS procedures.
•Physicians should review this surgical manual before surgery.
Medical imaging
•MEG, PET, x-ray/fluoroscopy and diagnostic ultrasound are unlikely to affect the
Evoke™ System
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:
oLithotripsy
oElectrocautery
oExternal defibrillation
oRadiation therapy (any damage to the device by radiation may not be
immediately detectable).
oUltrasonic scanning
oHigh-output ultrasound
oTENS
oPsychotherapeutic procedures (e.g. electroconvulsive therapy, transcranial
magnetic stimulation).
oLaser procedures
If the patient is required to undergo any of these therapies:
1. Turn off stimulation
2. Disconnect the eCLS if one is in use
3. Ensure all fields, electrodes, probes and/or ground plates are as far away as
possible from the Evoke™ System.
4. Use the lowest energy setting needed for the therapy.
5. Check the functioning of the Evoke™ System after the procedure and contact
Saluda Medical if any problems are apparent.
6. Use bipolar mode for electrical therapies if available
Operating equipment
•Patients may be distracted from operation of equipment if there are sudden
stimulation changes.
•Patients should turn stimulation off before operating automobiles, other vehicles, or
potentially dangerous equipment.

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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:
olifting more than 2.2 kg (5 lbs);
ophysical activities requiring stretching, bending or twisting;
oraising their arms above their head.
•Patients may experience temporary pain at the implant site as the incisions heal
after the surgery.
•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.
Stimulator manipulation
•Patients should avoid manipulating the Evoke™ System through the skin as it may
cause damage, lead or CLS movement, pain, irritation, or skin erosion.
•If the CLS is “flipped” over inside the skin pocket it may no longer be able to be
charged.
Scuba diving
•Patients should always obtain advice from their clinician prior to any diving activities.
•Patients should not dive below 5 m (16 ft.) or use hyperbaric chambers above 150
kPa (1.5 atm).
•The CLS may be damaged at greater depths or pressures.
Implant failure
•It is possible for the stimulator to stop working due to failure of a component or
battery, or a broken wire.
•Patients should be advised to charge their stimulator fully and, if it still fails to work,
contact the Clinician.
Sterilization and storage
•All surgical and implantable components of the Evoke™ System are supplied sterile.
•The sterilized components of the Evoke™ System are sterilized using ethylene oxide.
•All Evoke™ sterilized components are single use only and should not be re-sterilized
or reused, because of the risk of infection and device malfunction.
•Please observe the storage conditions printed on the labels of each component –
particularly storage and transport temperature, which varies between components –
as inadequate storage could have a negative impact on shelf-life and sterility.
•Please observe the expiration dates printed on the labels and return any expired
product to Saluda Medical because of the risk of infection.

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•If the packaging appears to be damaged, please return it to Saluda Medical for
replacement.
•Patients should be advised to avoid storing the Evoke™ external accessories outside
the labeled temperature ranges or in steamy environments such as bathrooms and
to keep them dry.
Handling of the eCLS, EPC and Charger
•Patients should be advised to carry and hold their accessories carefully to protect
them from striking hard surfaces or being dropped.
•Patients should be advised to keep their accessories dry and never immerse them in
water.
•Patients 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™ Instructions for
Use.
•Avoid prolonged skin contact of the external system components (lead adapter, lead
adapter cable, lead adapter extension, eCLS, EPC, Charger and charging coil). Place
clothing or dressings between skin and external system components.
Disposal of the stimulator, EPC and Charger
•The CLS, eCLS, EPC and Charger contain batteries that could explode if they are
thrown into a fire.
•Dispose of your EPC batteries in accordance with your local laws regarding waste
electrical equipment.
•The CLS, eCLS, EPC and Charger should be returned to Saluda Medical.
Disposal of sharps and explanted implants
•Please dispose of any sharps and medical waste according to your usual procedures.
•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.
Potential Risks
Every surgery involves potential risks including death. In addition to these surgical risks, the
risks associated with the implantation and use of a spinal cord stimulation system include:
•Undesirable changes in stimulation sensation and/or location.
•Uncomfortable changes in stimulation (over and/or under stimulation).
•Persistent post-surgical pain at hardware implantation sites.