SALUDA MEDICAL Evoke User manual

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Evoke™ SCS System User Manual
Evoke SCS System Instructions for Use

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Table of Contents
1Description ................................................................................................................. 5
2Indications and contraindications ............................................................................... 6
2.1 Indications for use – What the Evoke System is used for ......................................... 6
2.2 Contraindications – When the Evoke System must not be used............................... 6
3Safety information...................................................................................................... 6
3.1 Warnings .................................................................................................................. 6
3.2 Precautions............................................................................................................... 9
3.3 Potential risks or side effects.................................................................................. 13
4Temporary trial stimulation ...................................................................................... 13
4.1 Percutaneous lead placement procedure............................................................... 14
4.2 Programming the temporary trial system (eCLS).................................................... 14
4.3 How it should feel................................................................................................... 14
4.4 Lead removal and next steps .................................................................................. 15
4.5 The eCLS ................................................................................................................. 15
4.5.1 Using the eCLS ................................................................................................. 15
4.5.2 eCLS battery..................................................................................................... 16
4.5.3 Stopping stimulation from the eCLS................................................................. 16
5Fully implantable Evoke System................................................................................ 17
5.1 Percutaneous lead and stimulator implant procedure ........................................... 17
5.2 Programming .......................................................................................................... 17
5.3 How it should feel................................................................................................... 18
5.4 The CLS ................................................................................................................... 18
5.4.1 Controlling the CLS .......................................................................................... 18
5.4.2 Charging the CLS battery ................................................................................. 18
5.4.3 Stopping stimulation from the CLS .................................................................. 18
6The Evoke Pocket Console (EPC)................................................................................ 19
6.1 EPC audio indicators ............................................................................................... 23
6.1.1 Switching audio indicators on and off ............................................................. 23
6.2 Changing the battery in your EPC ........................................................................... 24
7The Evoke Charger .................................................................................................... 24

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7.1 Charging your Evoke CLS using the Evoke Charger ................................................. 27
7.2 Charging your Evoke eCLS using the Evoke Charger ............................................... 28
7.3 Charger audio indicators......................................................................................... 28
7.4 Recharging your Evoke Charger.............................................................................. 28
8Maintenance of EPC, Charger and eCLS..................................................................... 29
9Disposal of devices.................................................................................................... 29
10 Patient ID Card.......................................................................................................... 29
11 Troubleshooting........................................................................................................ 30
12 Package contents ...................................................................................................... 33
13 Technical Specifications ............................................................................................ 33
13.1 Device Specifications........................................................................................... 33
13.1.1 Evoke CLS......................................................................................................... 33
13.1.2 Evoke eCLS....................................................................................................... 35
13.1.3 Evoke 12C Percutaneous Lead (includes Trial Leads) ....................................... 36
13.1.4 Evoke 12C Lead Extension................................................................................ 37
13.1.5 Lead Adapter Kit .............................................................................................. 37
13.1.6 Evoke EPC ........................................................................................................ 39
13.1.7 Evoke Charger.................................................................................................. 40
13.2 Wireless Communication .................................................................................... 41
13.2.1 Quality of Service & Wireless Coexistence ....................................................... 41
13.2.2 Wireless Security ............................................................................................. 41
13.3 Electromagnetic Interference ............................................................................. 42
13.3.1 Guidance and Manufacturer’s Declarations .................................................... 42
14 Glossary and symbols................................................................................................ 45
14.1 Glossary .............................................................................................................. 45
14.2 Symbols............................................................................................................... 45
15 Regulatory Statements ............................................................................................. 47
16 Contact us................................................................................................................. 47

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Trademarks
Saluda, Evoke, and the Saluda Medical logo are either trademarks or registered trademarks
of Saluda Medical Pty Ltd.
Copyright © 2019 Saluda Medical Pty Ltd, Sydney, Australia. All rights reserved.
Refer to the Evoke SCS System MRI Guidelines for information on the safe
use of the Evoke System in an MRI environment.
Manuals are accessible at: http://www.saludamedical.com/manuals.

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1Description
This User Manual is intended for patients who have received the Saluda™ Medical Evoke™
SCS System for either a temporary trial or as a fully implanted system.
The Evoke SCS System is a closed loop spinal cord stimulation (SCS) system that is intended
to be used to treat chronic pain of the trunk and/or limbs. It stimulates the nerves in your
spinal cord, measures their responses, and can automatically adjust the stimulation level
accordingly.
Before receiving a fully implanted system, you will go through a temporary trial period
where you and your doctor can evaluate the system. If you and your doctor feel that the
Evoke SCS System is right for you, you may decide to move to a fully implanted system.
The Evoke SCS System comprises several key parts to deliver your therapy:
•Evoke External Closed Loop Stimulator (eCLS). During the trial stimulation period, your
percutaneous leads will be connected to the Evoke eCLS. The eCLS is an external
stimulator that you wear during your trial stimulation period. The eCLS delivers automatic
or manually controlled therapy through your percutaneous leads.
•Evoke Closed Loop Stimulator (CLS). The Evoke CLS is a totally implanted spinal cord
stimulator that connects to your percutaneous leads and is implanted under the skin for
long-term therapy. The CLS delivers automatic or manually controlled therapy through
your percutaneous leads.
•Evoke 12C Percutaneous Leads. The Evoke 12C Percutaneous Leads are placed in the
epidural space overlying your spinal cord, and are connected to the eCLS for a trial
period, or permanently implanted and connected to the CLS for long-term therapy. You
may have 1 or 2 percutaneous leads implanted, and there are 12 electrodes on each lead.
This gives your clinician the ability to find the stimulation settings that best give you pain
relief.
•Evoke 12C Lead Extensions. The Evoke 12C Lead Extensions may be used during the trial
period to connect your leads to the eCLS, or they may be permanently implanted to
connect the leads to the CLS if required. Your surgeon will determine if lead extensions
are required.
•Evoke Lead Adapter Kit. The Evoke Lead Adapter, Lead Adapter Cable and Lead Adapter
Extension allow you to connect your eCLS to your leads or lead extensions during the trial
stimulation period.
•Evoke Pocket Console (EPC).The EPC allows you to control your therapy and monitor
your stimulator (either a CLS or eCLS). The EPC and the stimulator communicate with
each other wirelessly. The EPC kit also includes a magnet, which allows you to stop
stimulation from the CLS or eCLS without using the EPC.
•Evoke Charger.The Evoke Charger allows you to recharge the battery in your stimulator
(CLS or eCLS). The Charger coil (attached to the Charger) is placed on clothing covering

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the skin over the implanted CLS and charge is transferred wirelessly to the CLS. The eCLS
is recharged by placing the Charger coil directly over the eCLS case. The Charger is battery
operated, and a power adapter is included in the kit for recharging the battery in the
Charger.
2Indications and contraindications
2.1 Indications for use – What the Evoke System is used for
The Saluda Medical Evoke System is indicated as an aid in the management of chronic
intractable pain of the trunk and/or limbs.
2.2 Contraindications – When the Evoke System must not be used
The Evoke System must not be used in patients who:
•Are unable to operate the Evoke System.
•Are unsuitable surgical candidates.
•Are unsuitable candidates for SCS.
3Safety information
3.1 Warnings
Diathermy
•You 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
tissue damage, severe injury, or death.
•It may also cause damage to the CLS and you may need surgery to replace it.
Magnetic Resonance Imaging (MRI) scans
The Evoke System is MR Conditional depending on how your system is
implanted and depending on how the MRI scan is performed.
•The clinical staff who will perform the MRI scan must exactly follow the instructions
in the Evoke SCS System MRI Guidelines.
•There are specific recommendations for MRI scans once implanted with the Evoke
System:
oIf you are undergoing a trial stimulation period with externalised leads, you
should not undergo an MRI scan.

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oIf an MRI scan is suggested for you, it is extremely important that you inform
the clinician recommending the MRI scan that you have an implanted SCS
system, along with the clinical staff who will perform the MRI scan.
oIt is also extremely important that you tell your doctor who looks after you in
relation to your stimulator, if an MRI scan is suggested for you.
oUnder specific conditions, you may be able to have an MRI scan of your head
or knee, but under no circumstances should you have an MRI scan of your
trunk/full body.
oAll external components of the Evoke System (e.g. Evoke Pocket Console,
Evoke Charger and magnet) are MR Unsafe and must be removed before
entering a room where an MRI scanner is located.
•MRI scans that are not performed according to the Evoke SCS System MRI Guidelines
may:
oCause significant heating resulting in tissue damage, severe injury, or death.
oDamage the CLS and you may need surgery to replace it.
oCause unintended stimulation such as tingling, shocking or jolting.
Specific information for doctors and radiological staff detailing the safe conditions for
MRI scanning with the Evoke System can be found in the Evoke SCS System MRI
Guidelines, accessible at http://www.saludamedical.com/manuals.
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.
•You should turn your stimulator off before undergoing a CT scan.
Implanted cardiac pacemakers or defibrillators may be affected by your Evoke System
•You should not use your Evoke System if you have any implanted cardiac devices,
due to interference between them.
•The effect of other implanted stimulators on your Evoke System is unknown. We
recommend that you should consult your doctor before undergoing implantation of
other medical devices.
Strong electromagnetic fields may cause you discomfort
•Avoid strong electromagnetic fields as they may cause your stimulator to switch off,
cause an uncomfortable or jolting sensation, or affect communication with your EPC.
•Your stimulator may be affected by:
oSecurity screeners such as those used at department stores, public buildings,
and airports – present your Patient ID Card and request to go around the
screener.
Turn stimulation off if you are required to go through the scanner.

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oPower cables and generators.
oElectric arc-welding devices and electric steel smelters.
oAudio speakers that contain strong magnets.
oAnti-theft devices used in shops and libraries.
oRadio communication transmitters or antennas, such as CB radio antennas
(see Section 13.3).
•If you feel an effect in your stimulation from an electromagnetic field, turn off your
stimulator and move out of the space as quickly as you can.
•Discuss with your doctor before entering any area that may affect how your
stimulator works, including areas displaying a warning notice preventing entry by
patients fitted with a pacemaker.
You should not charge the stimulator while sleeping, or with the Charger or Charger
coil against your skin.
•The Charger, Charger coil and/or CLS/eCLS may become hot during charging.
•If you lie on or lean against the Charger, Charger coil, or eCLS, it may heat up enough
to cause skin redness, skin irritation or a burn.
•Ensure there are no metal objects between the Charger coil and the stimulator
during charging, as the metal object may heat up and cause skin redness, skin
irritation or a burn. Additionally, the Charger may not operate correctly.
•The Charger unit may become hot during use, with a surface temperature reaching
48 °C (118 °F). Do not hold the Charger unit for longer than 10 minutes during use to
prevent risk of skin irritation, redness or injury.
•If you experience pain or discomfort during charging, you should stop and contact
your clinician.
Before any other surgical procedures, notify your clinician or dentist that you have an
implanted stimulator
•Some surgical procedures use electrical current that could affect your implanted
stimulator and leads, cause serious injury to you, and/or may damage your
stimulator.
•Before any procedure, tell your clinician that you have an implanted stimulator so
they can conduct the procedure without using electric current near your implanted
stimulator or leads.
If you may be allergic to parts of the stimulation system you should not be
implanted with a stimulator
•If you are allergic to some metals or plastics, please notify your clinician so that they
can check whether the items you are allergic to are used in the stimulation system.

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Cables and small parts
•The cables in this system pose a strangulation risk. To avoid strangulation, be careful
when using cables and keep out of the reach of children.
•Small parts and accessories could be hazardous if swallowed or cause choking if
ingested or inhaled. Keep small parts and accessories out of the reach of children.
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.
3.2 Precautions
You must inform your clinician that you have an implanted stimulator before
undertaking other treatments. Ask your clinician to refer to the Evoke SCS System Surgical
Guide for information on precautions to follow for the following treatments:
•Lithotripsy, which uses sound waves to disintegrate gallstones and kidney stones.
•Electrocautery or electrosurgery, which uses an electric current to cut tissue and
stop bleeding during surgery.
•External defibrillation, which uses a strong electric shock to the chest wall to restore
rhythm to the heart.
•Radiation therapy or radiotherapy, which uses ionising radiation, usually to control
or kill malignant cancer cells.
•Ultrasound and Doppler ultrasound, which uses very high frequency sound waves to
create images of your internal organs or to monitor the state of a pregnancy.
•High intensity ultrasound, which uses very high frequency sound waves to create
heat inside bones or muscle.
•Psychotherapeutic procedures such as Transcranial Magnetic Stimulation or
Electroconvulsive Therapy
Operating equipment
The Evoke System is a SCS system that measures the patient’s Evoked Compound Action
Potential (ECAP) in response to stimulation, and adjusts the amplitude of stimulation in
order to maintain stable coverage of painful areas. This is known as Feedback Controlled
stimulation.
When the stimulator is operating in feedback control mode:
•The Evoke System is less likely to produce sudden changes in stimulation that may
distract you while driving or operating equipment.
•You may leave stimulation on while operating automobiles, other vehicles, or
potentially dangerous equipment.

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•If you are charging the stimulator, Feedback Control mode is disabled, so you should
turn stimulation off if charging while driving or operating equipment.
•If you ever experience sudden changes in stimulation in Feedback Control mode, you
should turn stimulation off before driving or operating equipment. In this case, you
should contact the clinic to reprogram the Feedback Control mode settings in the
stimulator.
If the stimulator is not operating in Feedback Control mode:
•You may be distracted from operation of equipment if there are sudden stimulation
changes.
•You should turn stimulation off before operating automobiles, other vehicles, or
potentially dangerous equipment.
Be especially careful in the six to eight weeks after your surgery
•In the first six to eight weeks post-operative, your body will still be healing from the
surgery, and the implant or leads may move with some activities.
•Do not lift heavy objects greater than 5 kg (11 lb.).
•Try to limit bending, stretching or twisting as much as possible.
•Try to avoid raising your arms above your head repetitively.
•You may experience temporary pain at the implant site as the incisions heal after the
surgery.
•If you notice redness or feel irritation at the wound site, contact your clinician to
check for infection.
Do not try to move your stimulator by pushing it under your skin
•It is normal to be able to feel the stimulator under your skin – do not try to move it
or relocate it by pushing or massaging your skin.
•If you move your stimulator, it may flip over and you will not be able to charge it.
•Moving the stimulator may damage the leads or cause pain, irritation or thinning of
the skin over the stimulator.
Scuba diving
•You should always obtain advice from your clinician prior to any diving activities.
•You 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.
If you suspect part of your system is not working properly
If you are having problems with your system, first consult Section 11 ‘Troubleshooting’. If
this does not help or you have more questions please contact your clinician.

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Do not modify or tamper
•Do not modify or tamper with your Evoke Pocket Console (EPC), your Evoke Charger
or your external Closed Loop Stimulator (eCLS, if you have been given one).
Modifying or tampering with your equipment could cause these items not to work at
all, or to operate in an unpredictable way. This could lead to a loss of therapy.
•Do not connect anything to the eCLS or Charger that is not supplied as part of the
Evoke System. The eCLS should only be connected to the lead adapter cable or lead
adapter extension (refer to Section 4.5.1 Using the eCLS). The Charger should only be
connected to the supplied power adapter. Connecting these devices to other,
unsupported items could damage them and lead to a loss of therapy.
Protect the eCLS, EPC and Charger from extreme heat, cold or humidity
The electronics in your devices can be damaged by extreme heat, cold and humidity.
•Do not leave your devices in your car or outdoors for extended periods of time.
•Do not store your devices in humid environments, such as the bathroom.
•Avoid storing the eCLS at temperatures below -10°C (14 °F) or above 55 °C (131 °F).
•Avoid storing the EPC and Charger at temperatures below -20 °C (-4 °F) or above
60 °C (140 °F).
•Allow your devices to reach room temperature for 30 minutes before use if they
have been stored in cold or warm conditions.
•Only use the eCLS and EPC at room temperatures of 5 °C (41 °F) to 40 °C
(104 °F).
•Only use the Charger at room temperatures of 5 °C (41 °F) to 30 °C (86 °F). Do not
use the Charger if the room temperature is above 30 °C (86 °F).
Treat your eCLS, EPC and Charger gently
•Carry and hold your accessories carefully to protect them from striking hard surfaces
or being dropped.
•Try to keep your accessories dry, and never immerse them in water.
•Do not plug the Charger into outlets that are in humid environments – such as a
bathroom – or near water.
•Ensure you can always access your EPC, and keep a spare set of AAA batteries at
home for the EPC.
•Be sure to plug in the power cable for the Charger somewhere easy to access.
•If you need to clean your accessories, refer to Section 8 Maintenance of EPC, Charger
and eCLS.
•The Serial connection on the Charger is for Saluda Medical representative
use only. This connection is protected by a silicone plug. Ensure the plug is fully
inserted at all times.

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Avoid prolonged contact of the external parts on your skin
•External parts are the lead adapter, lead adapter cable, lead adapter extension, eCLS,
EPC, and Charger with Charger coil.
•Place clothing or dressings between your skin and these external parts.
Battery Care
The EPC is powered by two disposable AAA alkaline batteries. Observe the following
guidelines for safe use of batteries with your EPC:
•Insert batteries in the correct orientation by observing the plus (+) and minus (-)
marks on the batteries and the EPC.
•Do not mix batteries that differ by manufacturer, brand, type, age or previous usage.
•Replace both batteries at the same time.
•Do not touch the battery contacts in the EPC.
•Do not short-circuit batteries (e.g. do not let terminals of batteries contact each
other, do not place batteries loose in pockets, etc.).
•Do not disassemble, deform, immerse in water, or dispose of batteries in fire.
•Wipe batteries with a clean dry cloth if they become dirty.
•Store unused batteries in original packaging, in a clean and dry place.
•Do not use damaged or deformed batteries. If skin or eyes come into contact with
battery fluid or liquid, wash out with water and seek medical attention immediately.
•Do not expose batteries to heat (e.g. never leave batteries in sunlight, behind a
window or in a car).
•Do not recharge batteries.
•Dispose of used batteries promptly and carefully, in accordance with local
regulations. Keep away from children.
The eCLS and Charger are powered by internal rechargeable lithium ion batteries that
you cannot replace. The eCLS is recharged wirelessly by the Charger.
•Only use the power adapter supplied by Saluda Medical to recharge the Evoke
Charger.
•Do not touch the power adapter socket on the Charger.
•Do not leave the Charger power adapter plugged in after recharging is complete.
Disposal of your stimulator, EPC and Charger
•Your eCLS, EPC and Charger should be returned to your physician if you are no longer
using them.
•Your eCLS, EPC and Charger contain batteries that could explode if they are thrown
into a fire.

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3.3 Potential risks or side effects
All medical procedures involve some risk of injury, including death. In addition, there may
be risks associated with having a SCS system that are presently unknown or unforeseeable.
In spite of all reasonable precautions, you might develop medical complications from having
a SCS system.
Potential risks of implantation and use of a SCS system
•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.
•CLS migration, which may result in pain or difficulty in charging.
•Seroma or hematoma at surgery sites.
•Epidural haemorrhage, spinal cord injury and possible paralysis.
•Lead migration from the location chosen at initial implantation resulting in
stimulation changes.
•Breakage of the lead or failure of other system components, which may result in loss
of stimulation.
•Rejection of, or allergic reaction to, the implanted components.
•Infection that may require hospitalisation with intravenous antibiotic therapy.
•Infection that may result in epidural abscess that can lead to neurological harm
•Cerebrospinal fluid (CSF) leakage.
•Inadequate pain relief following system implantation.
•Erosion of the lead, lead extension or CLS through the skin.
•Weakness, clumsiness, numbness or pain below the level of lead implantation.
Note: You may require surgery (including revision, explant and/or replacement) as a result
of any of the above.
4Temporary trial stimulation
To test whether you will get a benefit from the Evoke spinal cord stimulation therapy, you
may have a temporary trial stimulation period.
•The trial usually lasts for up to a week, although some trials may last up to 30 days.
•During this trial stimulation period, you will have one or two 12C percutaneous leads
temporarily implanted in your spine by your clinician in a minor surgical procedure.
•After the surgery, the leads will be connected to an eCLS to deliver stimulation
pulses through your leads to your spine.
oYour eCLS is rechargeable and will be supplied fully charged.
•You will control the eCLS with the EPC.

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4.1 Percutaneous lead placement procedure
The leads will be implanted in your back near your spinal cord:
•In this procedure you will lie face down, awake but sedated.
•Your skin will be cleaned and anesthetised with a local anesthetic.
•The surgeon will slide a small needle in your spine.
•A lead is inserted through the needle near the spinal cord.
•The surgeon may elect to turn the stimulation on to take recordings from your spinal
cord, or to test the stimulation, to make sure it is in the correct place in your back.
You may feel stimulation pulses (tingling) in various areas of your body at this time.
•The surgeon may move the lead to get a better position.
•This process is repeated if you require a second lead.
•Once the leads are positioned correctly, they could be attached to an extension lead,
then anchored with a small anchor device under the skin, or simply brought through
the skin.
•The leads or extension lead will be taped in place, then covered with a dressing and
connected to the Evoke eCLS.
•Ensure that the EPC, eCLS, lead adapter, lead adapter cable and lead adapter
extension do not touch your skin for a prolonged time. Place clothing or dressing
between your skin and these external parts.
•After surgery, the eCLS will be programmed to deliver therapy according to your
needs.
4.2 Programming the temporary trial system (eCLS)
•Your clinician will customise a program to fit your needs.
•The device can store up to four different programs in your eCLS, and you can access
these programs using your EPC (refer to Section 6).
•Your eCLS may be required to be reprogrammed at any time during your trial period.
4.3 How it should feel
•Patients report that the feeling of using a stimulator ranges from nothing through to
a tingling sensation.
Caution: If you feel any uncomfortable sensations, such as shocks, jolts,
burning, pain or cramping around the chest or abdomen, use your EPC to adjust the
level of stimulation (refer to Section 6).
•If your therapy remains uncomfortable, contact your clinician so they can reprogram
your device to restore comfortable therapy for your pain relief.
•At the end of your trial stimulation period, your clinician will ask about the amount
of pain relief you experienced with the Evoke System.

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oIf you and your clinician agree that your pain relief was enough (usually
greater than 50% reduction in pain scores), then you will be asked to consider
getting a fully implanted Evoke System.
oIf you decide to get a fully implanted Evoke System, you can expect that the
sensations you feel and the amount of pain relief will be similar to the trial
period.
4.4 Lead removal and next steps
•At the end of the trial stimulation period your leads or extension will be removed.
•The dressings and any tape or sutures will be removed.
•The leads will then be withdrawn.
•This is a brief procedure and you should not feel any pain.
•The wound will then be dressed to allow healing.
•If you decide to get an implanted Evoke System, the leads will be inserted at a similar
location after your wounds from the trial have healed.
Note: If you had a lead extension and decide to get an implanted Evoke System, this
extension will be cut and remain under the skin in your back. When you receive the fully
implantable system, it will be removed.
Note:You may notice some differences between stimulation during the trial and with the
implanted stimulator, as the permanent leads may not be implanted in exactly the same
place as the trial.
4.5 The eCLS
Figure 4.1: The eCLS.
4.5.1 Using the eCLS
During the trial stimulation period, you may wear the eCLS in a pouch or as comfortable for
you.
The leads are connected to a lead adapter and lead adapter cable, and the lead adapter
cable is connected to the eCLS. Do not wear the eCLS, lead adapters, lead adapter cable or

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lead adapter extension on your skin for a prolonged time. Place clothing or dressing
between your skin and these external parts.
Ideally, you will leave the eCLS and leads connected to each other during the trial process.
If you need to disconnect the eCLS for any reason:
1. Turn the stimulation off using your EPC (refer to Section 6).
2. Disconnect the lead adapter cable from the eCLS.
•Do not remove the leads from the lead adapter.
3. To reconnect, plug the lead adapter cable into the eCLS socket (see Figure 4.2).
•When connecting, ensure that the arrow on the lead adapter cable connector
is facing the arrow on the eCLS cable.
Note: You may also have a lead adapter extension between the lead adapter cable
and the eCLS. You connect this extension in the same way as the lead adapter cable.
4. Turn stimulation on using the EPC (refer to Section 6).
Caution: If your EPC is on and the ‘Contact Clinician’ indicator on your EPC
remains lit, stimulation will not start and you must contact your clinician.
Figure 4.2: Connecting the lead adapter cable to the eCLS.
4.5.2 eCLS battery
The battery in the eCLS is rechargeable. It will be provided to you fully charged and should
last the duration of your trial. However, for longer trials, the battery may deplete so you
may be provided with a Charger.
The ‘Stimulator Battery’ indicator on the EPC (see Section 6) will show a single orange bar
when it is time to recharge the eCLS (see Section 7).
4.5.3 Stopping stimulation from the eCLS
There are two ways to stop therapy:

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•Switch on the EPC by pressing .
•Press to stop the therapy, or
•Hold the provided magnet over the eCLS for 2-3 seconds until you feel stimulation stop.
Note: If you have misplaced the supplied magnet, please contact your clinician.
Caution: Do not hold the magnet over the eCLS for longer than 10 seconds or the
eCLS will shut down. When the eCLS is shut down, the EPC will not control the eCLS. To
restart the eCLS you must start charging (see Section 7). Once charging has started you
will be able to control the eCLS with the EPC again (see Section 6).
5Fully implantable Evoke System
If you have a successful trial stimulation period, you and your doctor may decide to proceed
to a fully implanted Evoke System, which includes the CLS, 12C leads, lead extensions if
required, the EPC and Charger. You should return your trial EPC, Charger (if applicable) and
eCLS to your clinician.
5.1 Percutaneous lead and stimulator implant procedure
1. The 12C percutaneous leads will be implanted in your spine by your clinician in a
surgical procedure similar to the temporary trial stimulation procedure described in
Section 4.1.
2. The leads will be secured to prevent movement.
3. The leads (or lead extensions if required) are then tunneled under the skin to the
stimulator.
4. The leads or lead extensions will be connected to the CLS and the CLS will be placed
0.5 cm to 2.0 cm (0.2 in to 0.8 in) under the skin at the top of the buttocks, the flank,
abdomen, or other site, as chosen by you and your doctor.
a. You should tell your doctor on which side you would like the CLS to be
implanted.
5. The incisions at the lead insertion site and at the stimulator site will be closed and
covered with a dressing.
5.2 Programming
•After surgery, the CLS will be configured to deliver therapy according to your needs.
•Your clinician can store up to four different programs – customised to your needs –
in your stimulator. You can access these programs using your EPC (refer to Section
6).
•Your stimulator may be re-programmed at any time if required.

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5.3 How it should feel
•Patients report that the feeling of using a stimulator ranges from nothing through to
a tingling sensation.
Caution: If you feel any uncomfortable sensations, such as shocks, jolts,
burning, pain or cramping around the chest or abdomen, use your EPC to adjust the
level of stimulation (refer to Section 6).
•If your therapy remains uncomfortable, contact your clinician so they can reprogram
your device to restore comfortable therapy for your pain relief.
5.4 The CLS
Figure 5.1: The CLS.
The CLS is a fully implanted version of the eCLS you used in the trial.
5.4.1 Controlling the CLS
Use the EPC (see Section 6) to control the CLS.
5.4.2 Charging the CLS battery
The battery in the CLS needs to be recharged regularly in order to continue delivering
therapy. You charge the CLS using the Charger described in Section 7.
5.4.3 Stopping stimulation from the CLS
There are two ways to stop therapy:
•Switch on the EPC by pressing .
•Press to stop the therapy, or

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•Hold the provided magnet over the stimulator site for 2-3 seconds until you feel
stimulation stop.
Note: If you have misplaced the supplied magnet, please contact your clinician.
Caution: Do not hold the magnet over the CLS for longer than 10 seconds or the
CLS will shut down. When the CLS is shut down, the EPC will not control the CLS. To
restart the CLS you must start charging (see Section 7). Once charging has started you
will be able to control the CLS with the EPC again (see Section 6).
6The Evoke Pocket Console (EPC)
Figure 6.1: The EPC to control your stimulator (CLS or eCLS).
The EPC is used to control your therapy. The EPC is used for both the temporary trial
stimulation period to control to eCLS, and for the fully implanted CLS.
Your clinician will develop up to four different therapy programs (refer to Section 5.2) that
you can toggle between using the button. Each program is customised to your needs.
Stimulator Battery
Level indicator
Therapy Intensity
indicators
Selected Program
indicators
EPC On/Off button
Contact Clinician indicator
Change Program button
EPC Low Battery indicator
Decrease Therapy button
Increase Therapy button
Stop button

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EPC On/Off button
The ‘EPC On/Off’ button turns the EPC on and off.
Turn the EPC off to lock the buttons from changing your
therapy.
Note: When you turn the EPC on, all of the lights will flash
briefly. This is normal, and you should only pay attention to the
lights that remain on.
Note: You must turn on the EPC to stop stimulation, change
programs, turn stimulation on, change therapy intensity, or see
indicators.
Note: The EPC will turn off automatically after 2 minutes; the
stimulator will not turn off.
Stop button
Press the ‘Stop’ button to stop therapy immediately, for any
reason.
You can start therapy again after pressing the ‘Stop’ button by
pressing .
Caution:You must turn on the EPC before
you can use the ‘Stop’ button.
Increase Therapy and Decrease Therapy buttons
You can increase your therapy from nothing to a comfortable
level, using the ‘Increase Therapy’ button.
When you press the ‘Increase Therapy’ button to start
stimulation, it will ramp up to the last level (‘Therapy intensity’
indicator light) it was set to.