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.