SALUDA MEDICAL Evoke SCS System User manual

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saluda MEDICAL
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Evoke® SCS System User Manual
Evoke® SCS System User Manual
Instructions for the use of the Evoke SCS System
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Evoke® SCS System User Manual
Table of Contents
1 Description ....................................................................................................................4
2 Indications for use –What the Evoke System is used for .................................................5
3 Contraindications –When the Evoke System must not be used.......................................5
4 Safety information .........................................................................................................5
4.1 Warnings......................................................................................................................... 5
4.2 Precautions ..................................................................................................................... 8
4.3 Potential risks or side effects........................................................................................ 12
5 Temporary trial stimulation..........................................................................................13
5.1 Percutaneous lead placement procedure .................................................................... 13
5.2 Programming the External Closed-Loop Stimulator (eCLS).......................................... 14
5.3 How it should feel ......................................................................................................... 14
5.4 Lead or lead extension removal and next steps........................................................... 14
5.5 The eCLS........................................................................................................................ 15
6 Fully implantable Evoke System....................................................................................20
6.1 Percutaneous lead and stimulator implant procedure ................................................ 20
6.2 Programming ................................................................................................................ 20
6.3 How it should feel ......................................................................................................... 20
6.4 The CLS.......................................................................................................................... 21
7 The Evoke Pocket Console (EPC) ...................................................................................22
7.1 EPC buttons and indicators........................................................................................... 23
7.2 EPC audio indicators ..................................................................................................... 25
7.3 Changing the battery in your EPC ................................................................................. 26
8 The Evoke Charger........................................................................................................27
8.1 Charger buttons and Indicators .................................................................................... 27
8.2 Charging your Evoke CLS using the Evoke Charger....................................................... 30
8.3 Charger audio indicators............................................................................................... 31
8.4 Recharging your Evoke Charger.................................................................................... 31
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Evoke® SCS System User Manual
9 The Evoke Accessory Belt .............................................................................................32
9.1 Wearing the eCLS with the Accessory Belt................................................................... 32
9.2 Wearing the Charger Coil with the Accessory Belt....................................................... 33
10 Maintenance of EPC, Charger and eCLS.........................................................................34
11 Disposal of devices.......................................................................................................34
12 Patient ID Card.............................................................................................................34
13 Troubleshooting...........................................................................................................35
14 Package contents .........................................................................................................38
15 Technical Specifications................................................................................................38
15.1 Device Specifications .................................................................................................... 38
15.2 Wireless Communication.............................................................................................. 45
15.3 Electromagnetic Interference....................................................................................... 46
16 Glossary.......................................................................................................................50
17 Symbols .......................................................................................................................51
18 Contact us....................................................................................................................53
Trademarks
Saluda, Evoke, and the Saluda Medical logo are registered trademarks of Saluda Medical Pty
Ltd.
Copyright © 2022 Saluda Medical Pty Ltd, Sydney, Australia. All rights reserved.
Manuals are accessible at: http://www.saludamedical.com/manuals.
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1 Description
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. The eCLS
has a removable battery which is charged by a clinician or Saluda Medical
representative.
•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 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). The Charger coil (attached to the Charger) is placed on clothing covering the skin
over the implanted CLS and charge is transferred wirelessly to the CLS. The Charger is
battery operated, and a power adapter is included in the kit for recharging the battery in
the Charger.
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•Evoke Accessory Belt. The Evoke accessory belt is an elasticated belt with a pouch that
you wear to hold either the eCLS or Charger coil in place.
2 Indications for use –What the Evoke System is used for
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.
3 Contraindications –When the Evoke System must not be used
The Evoke SCS System should not be used in patients who:
•Do not receive effective pain relief during trial stimulation.
•Are unable to operate the Evoke SCS System.
•Are unsuitable surgical candidates.
4 Safety information
Although FDA has determined that the probable benefits outweigh the probable risks, there
remains some uncertainty on the long term systemic toxicity risks of the leads, lead extensions,
and anchors of the device. As a condition of approval, FDA is requiring the manufacturer to
provide additional long term systemic toxicity information.
4.1 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
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The Evoke System is considered MR Unsafe, as the safety of this system within an MRI
environment has not been tested.
•Under no circumstances should you have an MRI scan while you have the Evoke System.
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•Having an MRI scans while you have the Evoke SCS System may:
oCause significant heating resulting in tissue damage and/or severe injury.
oDamage the CLS and you may need surgery to replace it.
oCause unintended stimulation such as tingling, shocking or jolting.
•If an MRI scan is suggested for you, it is important that you inform the clinician
recommending the MRI scan that you have an implanted SCS system that is considered
MR Unsafe.
•It is also important that you tell your doctor who looks after you in relation to your
stimulator, if an MRI scan is suggested for you.
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.
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 15.3).
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•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 may become hot during charging.
•If you lie on or lean against the Charger or Charger coil, 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.
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.
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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.
4.2 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 use 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.
•Transcutaneous electrical nerve stimulation (TENS), which uses electric current to
stimulate nerves for therapeutic purposes.
•Psychotherapeutic procedures such as Transcranial Magnetic Stimulation or
Electroconvulsive Therapy.
•Laser procedures.
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 ECAP-controlled closed-loop
stimulation.
When the stimulator is operating with closed-loop stimulation enabled:
•You may leave stimulation on while operating automobiles, other vehicles, or potentially
dangerous equipment.
•If you are charging the stimulator, closed-loop is disabled, so you should turn
stimulation off if charging while driving or operating equipment.
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•If you ever experience sudden changes in stimulation with closed-loop enabled, you
should turn stimulation off before driving or operating equipment. In this case, you
should contact the clinic to reprogram the closed-loop settings in the stimulator.
If the stimulator is operating with closed-loop stimulation disabled:
•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 week after your surgery, 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 11 lb. (5 kg).
•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 16 ft (5 m) or use hyperbaric chambers above 1.5 atm
(150 kPa).
•Your stimulator 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 13 ‘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 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 Charger should only be connected to the supplied power adapter. Only
your clinician should connect the eCLS to lead adapters and recharge or replace the eCLS
battery (refer to Section 5.5.1 ‘Using the eCLS’). 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 14 °F (-10°C) or above 131 °F (55 °C).
•Avoid storing the EPC and Charger at temperatures below -4 °F (-20 °C) or above 140 °F
(60 °C).
•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 41 °F (5 °C) to 104 °F (40 °C).
•Only use the Charger at room temperatures of 41 °F (5 °C) to 86 °F (30 °C). Do not use
the Charger if the room temperature is above 86 °F (30 °C).
•Do not open the eCLS case to avoid exposing the eCLS to damaging moisture or
humidity.
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 adapter for the Charger somewhere easy to access.
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•If you need to clean your accessories, refer to Section 10 ‘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.
Device malfunction or failure
If any of your devices, including your eCLS, EPC and, Charger, are damaged, malfunction, fail,
become uncomfortably hot, emit smoke or a strange smell, switch the device off immediately,
stop use and contact your clinical team.
•Continued use of damaged or malfunctioning devices may cause electrocution, burns,
contact with hazardous chemicals, or uncomfortable stimulation.
•Please contact your clinician in the event of any device malfunction or failure.
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 Charger is powered by internal rechargeable lithium ion batteries that you cannot
replace.
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•Only use the power adapter supplied by Saluda Medical to recharge the Charger.
•Do not touch the power adapter socket on the Charger.
•Do not leave the Charger power adapter plugged in after recharging is complete.
The eCLS is powered by a rechargeable lithium ion battery that can be recharged or replaced
only by your clinician or a Saluda Medical representative.
•Do not open the case of your eCLS, remove or tamper with the eCLS battery.
•Please contact your clinic for recharge or replacement of your eCLS battery.
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.
4.3 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. Despite
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).
•Temporary or persistent post-surgical pain at hardware implantation sites.
•CLS migration or sub-optimal placement, which may result in pain or difficulty in
charging.
•Seroma or hematoma at surgery sites.
•Epidural hemorrhage, spinal cord injury, possible paralysis or other neurological
complications.
•Lead migration or sub-optimal placement, which may result in undesirable stimulation
changes.
•Breakage of the lead, or malfunction or failure of other system components, which may
result in undesirable changes or loss of stimulation.
•Allergic response or tissue reaction to the implanted or external materials.
•Infection that may require hospitalization with intravenous antibiotic therapy.
•Infection that may result in epidural abscess that can lead to neurological harm.
•Cerebrospinal fluid (CSF) leakage with possible fistula formation.
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•Gastrointestinal and/or genitourinary disruption or compromise.
•Inadequate pain relief following system implantation or over time.
•Erosion of the implanted components through the skin.
•Weakness, clumsiness, numbness, abnormal sensations or pain.
•Skin irritation.
Note: You may require surgery (including revision, explant and/or replacement) as a
result of any of the above.
5 Temporary 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
implanted in your spine by your clinician in a minor surgical procedure. Your surgeon
may also connect the leads to 12C lead extensions if required.
•After the surgery, the leads or lead extensions will be connected to an External Closed-
Loop Stimulator (eCLS) to deliver stimulation pulses through your leads to your spine.
oYour eCLS will be supplied fully charged. If the eCLS battery becomes depleted,
please return to your clinic for battery recharge or replacement.
•You will control the eCLS with the Evoke Pocket Console (EPC).
5.1 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 anesthetized 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.
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•Once the leads are positioned correctly, they could be simply brought through the skin,
or anchored with a small anchor device under the skin and attached to an extension
lead, which is then brought through the skin.
•The leads or lead extensions will be taped in place, then covered with a dressing and
connected to the eCLS.
•After surgery, the eCLS will be programmed to deliver therapy according to your needs.
5.2 Programming the External Closed-Loop Stimulator (eCLS)
•Your clinician will customize a program to fit your needs.
•Your eCLS can store up to four different programs, and you can access these programs
using your EPC (refer to Section 7).
•Your eCLS may be required to be reprogrammed at any time during your trial period.
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 7).
•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.
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.
5.4 Lead or lead extension removal and next steps
If you did not have lead extensions implanted:
•At the end of the trial stimulation period your leads 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.
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•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 (see Section 6).
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.
If you had a lead extension implanted and decide to get an implanted Evoke System:
•The lead extensions will be removed, but the leads will remain implanted and connected
to your implanted stimulator (see Section 6).
•If your implant surgery is scheduled for a later date after the trial period ends:
oAt the end of the trial, the lead extension will be cut and remain under the skin
in your back and the leads will remain implanted in the same place.
oThe wound will then be dressed to allow healing.
oWhen you receive the fully implantable system, the remaining cut lead
extensions will be removed and the leads that remained implanted after the trial
will be connected to your implanted stimulator (see Section 6).
If you had a lead extension implanted and decide not to get an implanted Evoke System:
•The leads, anchors and lead extensions will be removed.
•The wound will then be closed and dressed to allow healing.
5.5 The eCLS
Figure 5.1: The eCLS case. Your clinician will connect the eCLS to leads or lead extensions
inside the eCLS case. Do not open the eCLS case.
5.5.1 Using the eCLS
The trial leads or lead extensions are connected to lead adapters and the lead adapters are
connected to the eCLS by your clinician. Your clinician will then place the eCLS inside the eCLS
case (see Figure 5.1). During the trial stimulation period, you may wear the eCLS, in its case, in a
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pouch (see Section 9) or taped to your back. The eCLS and leads or extensions remain
connected during the trial period. If the leads or extensions become disconnected from the
eCLS, or you need to disconnect the eCLS for any reason, please contact your clinic.
Caution: Do not open the eCLS case. If your eCLS case opens please contact your
clinical team (refer to Section 5.5.4.2 Reconnecting the eCLS). If you have any issues with
the eCLS during your trial stimulation period, please contact your clinical team.
5.5.2 eCLS battery
The battery in the eCLS is rechargeable and/or replaceable. It will be provided to you fully
charged and should last the duration of your trial. If your eCLS battery is depleted during your
trial, you must return to your clinic to have the eCLS battery replaced or recharged.
The ‘Stimulator Battery’ indicator on the EPC (see Section 7) will show a single orange bar
when it is time to recharge the eCLS (see Section 8).
5.5.3 Stopping stimulation
There are two ways to stop therapy:
5.5.3.1 Using the EPC
1. Unlock the EPC by pressing .
2. Press to stop the therapy, or
5.5.3.2 Using a magnet
1. 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.
5.5.4 Do not open the eCLS case
Do not open the eCLS case or remove the eCLS from the case during your trial stimulation
period. Doing so could cause your leads or lead extensions to be pulled on, which may cause
the leads to move and your therapy to change.
If the eCLS case is opened, the leads become disconnected from the eCLS, or you need to
disconnect the eCLS for any reason, please contact your clinic.
Caution: Saluda Medical does not recommend that you attempt to disconnect or
reconnect your eCLS without assistance.
Caution: Please follow the advice of your clinical team. If you wish to disconnect or
reconnect your eCLS, only do so with assistance from a care-giver following the
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instructions below. Do not pull on the leads or extensions or apply tension between the
eCLS and the leads.
5.5.4.1 Disconnecting the eCLS
If you require the eCLS to be disconnected from the lead adapters, a care-giver should:
1. Turn stimulation off (see Section 5.5.3).
2. Open the eCLS case by separating the tabs on the eCLS case.
3. Remove the eCLS from the case.
4. Remove the lead adapters from the eCLS (see Figure 5.2), noting the port that each lead
adapter was removed from.
5. Secure the lead adapters to your back using adhesive tape to ensure they do not pull on
the leads.
If the lead adapters have been removed, you should return to the clinic to have the
components reconnected.
Caution: Do not remove the leads from the lead adapters. Do not pull on the leads
or extensions or apply tension between the eCLS and the leads while the lead adapters
are being disconnected from the eCLS.
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Port Numbers
~
PortSocket
Guide
for
Lead Adapter
Evoke® SCS System User Manual
Figure 5.2: The Lead Adapter and eCLS. Port 2 of the eCLS is shown here. Port 1 is on the other
side of the eCLS.
5.5.4.2 Reconnecting the eCLS
Caution: Saluda Medical does not recommend that you attempt to disconnect or
reconnect your eCLS without assistance.
Caution: Please follow the advice of your clinical team. If you wish to disconnect or
reconnect your eCLS, only do so with assistance from a care-giver following the
instructions below. Do not pull on the leads or extensions or apply tension between the
eCLS and the leads.
If you need to reconnect the lead adapters to the eCLS, please contact the clinic.
If your clinician instructs you to have a care-giver reconnect the components, they should:
1. Rest the lead adapter on the guide on the side of the eCLS and gently push the lead
adapter plug into the socket on the eCLS port until it clips into place (see Figure 5.2).
Note: The eCLS ports are labelled “1” on one side for lead 1 and “2” on the other side for
lead 2.
Note: Each lead adapter must be connected to the same port it was disconnected from.
If you feel stimulation has changed after reconnecting the components, your leads may
have been connected to the wrong eCLS port. If your stimulation has changed or you
have any issues, contact your clinic.
2. To reconnect the second lead adapter, repeat step 1.
3. Open the eCLS case and orient it as shown below (see Figure 5.3), with the orange seal
side on the left and the lead exits on the top.
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Evoke® SCS System User Manual
4. Orient the eCLS (with lead adapters connected) so that the battery is facing up and the
leads are exiting from the top.
5. Place the eCLS into the left side of the eCLS case (i.e. the orange seal side of the open
eCLS case; see Figure 5.3).
6. Place the leads into the slots in the seal at the lead exits.
Orange seal
Lead exits
Battery
Figure 5.3: Place the eCLS with leads connected into the eCLS Case.
7. While taking care to keep the leads in the slots in the seal, close the eCLS case by folding
the case shut until it snaps closed (see Figure 5.4).
Caution: The leads may be damaged when the case is closed if they are not in the
slots in the seal at the lead exits. This could disrupt your trial stimulation.
8. Secure the eCLS comfortably to your back using adhesive tape or the Evoke Accessory
Belt (See Section 9 ‘The Evoke Accessory Belt’). Avoid pulling on the leads or extensions,
or applying tension between the eCLS and the leads or extensions.
Figure 5.4 eCLS with two leads connected enclosed in the eCLS case.
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Evoke® SCS System User Manual
6 Fully 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 and eCLS to your clinician.
6.1 Percutaneous lead and stimulator implant procedure
1. If your leads were removed at the end of the trial stimulation period, then new 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 5.1.
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.
Note: 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.
6.2 Programming
•After surgery, the CLS will be configured to deliver therapy according to your needs.
•Your clinician can store up to four different programs, customized to your needs, in your
stimulator. You can access these programs using your EPC (refer to Section 7).
•Your stimulator may be re-programmed at any time if required.
6.3 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 7).
•If your therapy remains uncomfortable, contact your clinician so they can reprogram
your stimulator to restore comfortable therapy for your pain relief.
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