Saluda MEDICAL Evoke SCS System Instruction Manual
- June 3, 2024
- Saluda MEDICAL
Table of Contents
Evoke SCS System
Evoke® SCS System User Manual
Instructions for the use of the Evoke SCS System
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Table of Contents
Evoke® SCS System User Manual
1 Description. ……………………………………………………………………………………………………. 5 2 Indications for use
The reasons to use the Evoke System. …………………………………….. 6 3 Contraindications
When the Evoke System must not be used. ………………………………. 6 4 Safety
information. ………………………………………………………………………………………….. 6
4.1 Warnings. ………………………………………………………………………………………………………… 6 4.2 Precautions.
……………………………………………………………………………………………………. 9 4.3 Potential risks or side
effects……………………………………………………………………………. 14 5 Temporary trial stimulation.
……………………………………………………………………………. 15 5.1 Lead placement procedure.
……………………………………………………………………………… 15 5.2 Programming the External Closed-Loop
Stimulator (eCLS). ………………………………….. 15 5.3 How it should feel.
………………………………………………………………………………………….. 16 5.4 Lead or lead extension removal and
next steps. …………………………………………………. 16 5.5 The eCLS.
……………………………………………………………………………………………………….. 17 6 Fully implantable Evoke System.
………………………………………………………………………. 22 6.1 The CLS.
…………………………………………………………………………………………………………. 22 6.2 Lead and CLS implant
procedure. ……………………………………………………………………… 23 6.3 Programming.
………………………………………………………………………………………………… 23 6.4 How it should feel.
………………………………………………………………………………………….. 23 7 The Evoke Patient Controller (EPC).
…………………………………………………………………… 24 7.1 EPC buttons and
indicators………………………………………………………………………………. 25 7.2 EPC audio indicators.
………………………………………………………………………………………. 27 7.3 Changing the battery in your EPC.
…………………………………………………………………….. 28 7.4 Pair your EPC to your stimulator.
……………………………………………………………………… 28 7.5 Un-pair an EPC and
stimulator………………………………………………………………………….. 29 8 The Evoke Charger.
………………………………………………………………………………………… 29 8.1 Charger buttons and Indicators.
……………………………………………………………………….. 30 8.2 Charging your Evoke CLS using the Evoke
Charger………………………………………………. 32
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8.3 Charger audio indicators………………………………………………………………………………….. 33 8.4
Recharging your Evoke Charger………………………………………………………………………… 33 9 The Evoke
Accessory Belt. ……………………………………………………………………………….. 34 9.1 Wearing the eCLS with
the Accessory Belt. ………………………………………………………… 34 9.2 Wearing the Charger Coil
with the Accessory Belt………………………………………………. 35 10 Maintenance of EPC, Charger
and eCLS………………………………………………………………. 36 11 Disposal of
devices…………………………………………………………………………………………. 36 12 Patient ID
Card………………………………………………………………………………………………. 36 13
Troubleshooting…………………………………………………………………………………………….. 37 14 Package contents.
………………………………………………………………………………………….. 40 15 Technical Specifications.
…………………………………………………………………………………. 40 15.1 Device Specifications.
……………………………………………………………………………………… 40 15.2 Wireless Communication.
………………………………………………………………………………… 50 15.3 Electromagnetic Interference.
………………………………………………………………………….. 50 15.4 Federal Communications Commission
(FCC). ……………………………………………………… 54 16
Glossary……………………………………………………………………………………………………….. 56 17 Symbols.
………………………………………………………………………………………………………. 57 18 Contact
us…………………………………………………………………………………………………….. 59
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Evoke® SCS System User Manual
Trademarks Saluda, Evoke, and the Saluda Medical logo are registered
trademarks of Saluda Medical Pty Ltd. Copyright © 2021 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 and measures their responses. It
can then 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 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 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 leads. The CLS is implanted under
the skin for longterm therapy. The CLS delivers automatic or manually
controlled therapy through your leads.
Evoke CAP12 Percutaneous Leads. The Evoke CAP12TM Percutaneous Leads are
placed in the epidural space overlying your spinal cord. The leads 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 leads
implanted. 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 CAP12X Lead Extensions. The Evoke CAP12XTM Lead Extensions may be used
during the trial period to connect your leads to the eCLS. They may also be
permanently implanted to connect the leads to the CLS if required. Your
surgeon will determine if lead extensions are required.
Evoke Patient Controller (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.
The magnet 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. The charge is transferred
wirelessly to the CLS. The Charger is battery operated. 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 The reasons to use the Evoke System.
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.
4.1 Warnings.
Diathermy. You should not receive shortwave, microwave and/or therapeutic
ultrasound diathermy. Diathermy generates energy that may cause heating at the
lead site. This may result in
tissue damage, severe injury, or death. It may also cause damage to the CLS.
You may need surgery to replace the CLS.
Magnetic Resonance Imaging (MRI) scans.
The Evoke System is considered MR Unsafe. The safety of this system during an
MRI scan has not been tested.
You should not have an MRI scan while you have the Evoke System. Having an MRI
scan while you have the Evoke SCS System may:
o Cause significant heating resulting in tissue damage and/or severe injury. o
Damage the CLS. You may need surgery to replace it. o Cause unintended
stimulation such as tingling, shocking or jolting.
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If an MRI scan is suggested for you, it is important to tell the clinician
recommending the MRI scan that you have an implanted SCS system that is MR
Unsafe.
It is also important to tell your doctor who looks after you in relation to
your stimulator, if an MRI scan is suggested for you.
CT Scans. You may experience a brief increase in stimulation during a CT scan.
This may cause
uncomfortable stimulation, jolting or a shocking sensation. You should turn
your stimulator off before having a CT scan. Consult your doctor prior to
having 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. They
may interfere with each other. The effect of other implanted stimulators on
your Evoke System is unknown. You should
consult your doctor before having other medical devices implanted.
Strong electromagnetic fields may cause you discomfort. Avoid strong
electromagnetic fields. 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:
o Security screeners such as those used at department stores, public
buildings, and airports. Show your Patient ID card and ask to go around the
screener. Note: Your stimulator may set off the security screener. Turn
stimulation off if you have to go through the screener.
o Power cables and generators. o Electric arc-welding devices and electric
steel smelters. o Audio speakers that contain strong magnets. o Anti-theft
devices used in shops and libraries. o Radio communication transmitters or
antennas, such as CB radio antennas. See
Section 15.3. If you feel an effect in your stimulation from an
electromagnetic field, turn off your
stimulator. Move away as quickly as you can.
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Discuss with your doctor before entering any area that may affect how your
stimulator works. This includes areas with 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. The metal object may heat up and cause skin redness, skin
irritation or a burn. The Charger may also not work 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. This helps to prevent skin irritation, redness or injury.
If you feel 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. This may cause serious injury to you, and/or
may damage your stimulator.
Before any procedure, tell your clinician that you have an implanted
stimulator. They can then 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.
They can then check if the items you are allergic to are used in the Evoke
System.
Cables and small parts.
The cables in this system pose a strangulation risk. To avoid strangulation,
be careful when using cables. Keep them 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.
Follow the instructions in this user manual. Read and fully understand this
user manual for the use of the Evoke System. Please ask your clinician if you
have any questions.
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. This gives information on precautions to follow for the
following treatments:
Ultrasound and Doppler ultrasound. These use very high frequency sound waves
to create images of your internal organs or to monitor the state of a
pregnancy.
High intensity ultrasound. This uses very high frequency sound waves to create
heat inside bones or muscle.
Lithotripsy. This uses sound waves to disintegrate gallstones and kidney
stones.
Electrocautery or electrosurgery. These use an electric current to cut tissue
and stop bleeding during surgery.
Implanted parts of a system should not be exposed to therapeutic levels of
ultrasound energy. The implanted parts can inadvertently concentrate the
ultrasound field and cause harm.
External defibrillation. This uses a strong electric shock to the chest wall
to restore rhythm to the heart.
Radiation therapy or radiotherapy. This uses ionizing radiation, usually to
control or kill malignant cancer cells.
Ultrasound and Doppler ultrasound. These use very high frequency sound waves
to create images of your internal organs or to monitor the state of a
pregnancy.
High intensity ultrasound. This uses very high frequency sound waves to create
heat inside bones or muscle.
Transcutaneous electrical nerve stimulation (TENS). This uses electric current
to stimulate nerves for therapy.
Psychotherapeutic procedures such as Transcranial Magnetic Stimulation or
Electroconvulsive Therapy.
Laser procedures.
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Operating equipment. The Evoke System is a SCS system that measures the
patient’s Evoked Compound Action Potential (ECAP) in response to stimulation.
It adjusts the strength of stimulation to give stable coverage of painful
areas. This is known as ECAP-controlled closed-loop stimulation. When the
stimulation is on 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.
If you ever feel 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 stimulation is on 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. 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 feel 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 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 your skin over the stimulator.
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Scuba diving. You should always get advice from your clinician before scuba
diving. 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. Do not modify or tamper. Do not modify or tamper with your Evoke Patient Controller (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 work 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 5.5.1Using the
eCLS’). Connecting these devices to other, unsupported items could damage them
and lead to a loss of therapy.
Do not use accessories, transducers and cables other than those specified or
provided by Saluda Medical. This could result in increased electromagnetic
emissions or decreased electromagnetic immunity of this equipment. This could
result in improper operation.
Storing your magnet when not in use. Store magnet with the keeper (small metal
bar) in place. Keep the magnet away from heat sources.
Keep the magnet away from strong magnetic fields (e.g. other magnets). Handle
the magnet carefully to protect it from striking hard surfaces or being
dropped.
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 an extended time. Do not
store your devices in humid environments, such as the bathroom. Avoid
transporting or storing the eCLS at temperatures below 14 °F (-10°C) or above
131
°F (55 °C).
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Avoid transporting or 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 temperatures of 41 °F (5 °C) to 104 °F (40 °C).
Only use the Charger at temperatures of 41 °F (5 °C) to 86 °F (30 °C). Do not
use the Charger if the temperature is above 86 °F (30 °C).
Do not open the eCLS case. This may expose 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.
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 always fully
inserted.
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.
If you use damaged or malfunctioning devices it 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. Follow these
guidelines for safe use of batteries with your EPC:
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Insert batteries the correct way 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 your
skin or eyes contact 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. 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 should only be
recharged or replaced 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.
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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. These 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. These may result in
undesirable stimulation
changes. Breakage of the lead, or malfunction or failure of other system
components. These 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. 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.
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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 CAP12
percutaneous leads implanted in your spine by your clinician in a minor
surgical procedure. Your surgeon may also connect the leads to CAP12X lead
extensions if required.
After the surgery, the leads or lead extensions will be connected to an
External ClosedLoop Stimulator (eCLS) to deliver stimulation pulses through
your leads to your spine. o Your 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 Patient Controller (EPC).
5.1 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. They may 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 simply brought through the skin.
In some cases, it may be anchored with a small anchor device under the skin
and attached to a lead extension. The lead extension 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.
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Your eCLS may be required to be reprogrammed at any time during your trial
period.
5.3 How it should feel.
The feeling of stimulation 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. 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. o If 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. o If 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 taken out.
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. See Section
6. Note: You may notice some differences between stimulation during the trial
and with the implanted stimulator. This is because 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. The
leads will be connected to your implanted stimulator. See Section 6.
If your implant surgery is scheduled for a later date after the trial period
ends: o At the end of the trial, the lead extension will be cut and remain
under the skin in your back. The leads will remain implanted in the same
place.
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o The wound will then be dressed to allow healing. o When you receive the
fully implantable system, the remaining cut lead
extensions will be removed. 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 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 replaceable. It will be provided
to you fully charged. The battery should last the duration of your trial in
most cases. If your eCLS battery is depleted during your trial, you must
return to your clinic to have the eCLS battery replaced or recharged.
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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 7.4).
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. This 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 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.
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5. Secure the lead adapters to your back using adhesive tape. This ensures
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.
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).
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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. 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.
Lead exits
Battery
Orange seal
Figure 5.3: Place the eCLS with leads connected into the eCLS Case. 7. Take
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.
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Figure 5.4 eCLS with two leads connected enclosed in the eCLS case.
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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. This includes the CLS,
CAP12 leads, lead extensions (if required), the EPC, and Charger. You should
return your trial EPC and eCLS to your clinician.
6.1 The CLS.
Figure 6.1: The CLS. The CLS is a fully implanted version of the eCLS you used
in the trial.
6.1.1 Controlling the CLS.
Therapy delivered by the CLS can be controlled using your EPC. Refer to
Section 7 for instructions on how to use the EPC.
6.1.2 Charging the CLS battery.
The battery in the CLS needs to be recharged regularly in order to continue
delivering therapy. Refer to Section 7.4 for instructions on how to charge the
CLS using the Charger.
6.1.2.1 Battery Best Practices. You may prolong the life of your CLS battery
by: Recharging it periodically, even if it is not fully discharged. Recharging
it before it completely drains. Recharging it even if you are not using the
stimulator. Recharge at least once per year.
6.1.3 Stopping stimulation from the CLS.
There are two ways to stop therapy:
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6.1.3.1 Using the EPC.
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1. Unlock the EPC by pressing
.
2. Press
to stop the therapy
6.1.3.2 Using a magnet.
1. Hold the provided magnet over the implant 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 7.4). Once charging has started you will be able to control the CLS with the EPC again (see Section 7).
6.2 Lead and CLS implant procedure.
1. If your leads were removed at the end of the trial stimulation period,
then new CAP12 percutaneous leads will be implanted in your spine. Your
clinician will perform a surgical procedure like 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 CLS.
4. The leads or lead extensions will be connected to the CLS. 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. The site will be 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 CLS site will be
closed and covered with a dressing.
6.3 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
implant. You can access these programs using your EPC. Refer to Section 7.
Your implant may be re-programmed at any time if required.
6.4 How it should feel.
The feeling of stimulation ranges from nothing through to a tingling
sensation.
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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. They can reprogram your implant to
restore comfortable therapy for your pain relief.
7 The Evoke Patient Controller (EPC).
Figure 7.1: The EPC to control your stimulator (CLS or eCLS).
The EPC is for controlling your therapy. During the temporary trial
stimulation period, it controls the eCLS. After you receive a permanent
implant, it controls the CLS.
Your clinician will create up to four different therapy programs (refer to
Section 6.3) that you
can toggle between using the needs.
button. Each program is customized to your
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7.1 EPC buttons and indicators.
EPC Lock/Unlock button.
The EPC Lock/Unlock’ button turns the EPC on and off. Turn the EPC off to lock the buttons from being able to change your therapy. Turn the EPC on to unlock the buttons and see indicators. This enables you to stop stimulation, change programs, turn stimulation on, change therapy intensity, and check CLS and EPC battery levels. Note: When you turn the EPC on, all of the lights will flash briefly. This is normal; you should only pay attention to the lights that remain on. Note: The EPC will turn off and lock automatically after 2 minutes; this does not cause the stimulator to turn off. Stop button. Press theStop’ button to stop therapy immediately. After turning stimulation
off, you can start therapy again by
pressing
.
Caution: You must unlock the EPC before you can use the Stop’ button. Increase Therapy and Decrease Therapy buttons. You can increase your therapy, from off 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 it was set to (the level indicated by theTherapy intensity’ indicator light).
You can decrease your therapy using the `Decrease Therapy’ button.
Caution: You must unlock the EPC before you can use the Increase Therapy’ and Decrease Therapy’ buttons.
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The Therapy Intensity’ indicators will glow to reflect the level of your current therapy settings. You can change the level using theIncrease Therapy’ and Decrease Therapy’ buttons. The number of glowing bars may not change with every click of the button, although the level of therapy will change. When you have reached the maximum level for the current program, all seven bars will be glowing. When therapy is off, only one bar will glow. That bar indicates the level that you will start at when you press theIncrease
Therapy’ button.
Change Program button.
Use the Change Program’ button to switch between up to four different therapy programs stored in your stimulator. One of theSelected Program’ indicators
will glow to show the program you have selected.
1. Press the Change Program’ button once and theSelected Program’
indicator will start flashing.
2. Press the Change Program’ button again until the desired program is selected. 3\. After 2 seconds, theSelected Program’ indicator will stop flashing,
stimulation will turn off, and the stimulator will change to the new program.
4. Start therapy again using the
button
Caution: You must unlock the EPC before you can use the `Change Program’ button.
Stimulator Battery Level indicator
The `Stimulator Battery Level’ indicator shows the battery level in the stimulator, with three green bars indicating a full charge.
Caution: When the orange bar appears, the battery level is low. You should recharge it right away or therapy may stop soon.
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When the `EPC Low Battery’ indicator glows orange, it indicates that the EPC battery is low. You should replace the batteries as soon as you can (see Section 7.3).
Caution: If you do not change the batteries, they will discharge completely.
You will then not be able to use the EPC to make changes to your therapy.
Note: You can stop your therapy without the EPC by placing the provided magnet
over the implanted Evoke CLS or the eCLS.
Contact Clinician indicator.
The Contact Clinician’ indicator will glow orange if the stimulator has detected a problem. You may have you to visit your clinician for assessment. Note: TheContact Clinician’ indicator will not contact the clinician on your
behalf. It is a message to inform you that you should contact your clinician.
7.2 EPC audio indicators.
In addition to the visual indicators on the front of the EPC, the EPC will
beep to indicate various functions:
A short beep will occur every time you press a button.
A long beep means your EPC has successfully communicated its command to the
Evoke CLS or eCLS and a change has been made.
Two beeps indicates that the Evoke CLS or Evoke eCLS has reached a limit and
did not accept the request.
o This will occur if you are at 1 (bottom) Therapy Intensity’ indicator light and have tried to decrease the therapy. o This will occur if you are at 7 (top)Therapy Intensity’ indicator lights
and have tried to increase the therapy.
o If you think your stimulator needs to be reprogrammed, contact your
clinician.
Three beeps indicates that the Evoke CLS or Evoke eCLS did not receive the
request and a change was not made.
o Move the EPC closer to the CLS or eCLS and try again.
Six long beeps indicate that EPC batteries are running low and should be
replaced.
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Ten long beeps, followed by the EPC switching off, indicates that the CLS has
gone into Safe Mode. You should contact your clinician. If you have an eCLS,
it may mean that the eCLS battery needs recharging.
7.2.1 Switching audio indicators on and off.
Follow the steps below to turn off Audio indicators: 1. Turn the EPC off (if
it is not already off).
2. Press and hold the
button (until you complete the next step).
3. Press and hold the
button until the EPC turns on.
Note: When the audio indicators are off you will have no indication when the stimulator has reached a limit (2 beeps), or when the stimulator did not receive the request (3 beeps). For more information, refer to Section 7.2.
Follow the steps below to turn audio indicators back on.
1. Turn the EPC off.
2. Press and hold the
button (until you complete the next step).
3. Press and hold the
button until the EPC turns on.
7.3 Changing the battery in your EPC.
Two AAA alkaline batteries power the EPC.
To replace the batteries:
1. Slide open the back cover.
2. Remove the old batteries from the battery compartment and insert new ones.
Make sure the battery terminals are placed in the orientation that is marked
inside the battery compartment.
3. Replace the back cover.
7.4 Pair your EPC to your stimulator.
To enable the EPC to be used with an eCLS or CLS it must first be paired with
that stimulator using the following instructions. In most cases your clinician
will pair your EPC to your stimulator for you.
1. Ensure that there are no other stimulators nearby when you attempt to
pair. Pairing will not occur if the EPC detects more than one stimulator.
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2. With the EPC off, press and hold
and then press and hold
at the same time for more than 1 second to enter pairing mode.
While searching for the stimulator, the EPC will beep every 0.5 seconds for up to 10 seconds.
The EPC will emit one long beep if pairing is successful.
o The EPC will beep three times if pairing is unsuccessful because no stimulator could be detected.
o The EPC will beep four times if pairing is unsuccessful because more than one stimulator has been detected.
3. Press unsuccessful.
to start using the EPC or to start searching again if pairing was
7.5 Un-pair an EPC and stimulator.
The EPC can only be paired to one stimulator at a time. If you need to pair to
a different stimulator, you must restart pairing mode as shown in Section 7.4.
Note: You do not need to un-pair the EPC from the stimulator it is already
connected to before pairing with a different stimulator.
8 The Evoke Charger.
Charge coil
Charging Link indicator Contact Clinician indicator
CLS Battery Level indicator
Start Charging button
Charger Battery Level indicator
Figure 8.1: The Charger and Charger coil.
The Evoke Charger is used to charge the battery in your implanted CLS. The
Charger coil is used to wirelessly transfer charge to the CLS battery.
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8.1 Charger buttons and Indicators.
Start Charging button.
Place the Charger coil over the implant. Press the Start Charging’ button for more than 1 second to begin charging. Charging Link indicator. TheCharging Link’ indicator shows the quality of the link between the
Charger coil and the CLS.
No charging possible.
Charger will beep every
second.
Marginal alignment. Charging possible but may take
longer.
Acceptable alignment for
charging.
Charger will beep once if
the coil alignment falls below this quality.
Ideal alignment for
charging.
Note: To improve the quality of the link between the Charger coil and the Evoke CLS, move the coil closer to the implant.
Charger Battery Level indicator.
The `Charger Battery Level’ indicator shows the battery level in the Charger.
Caution: As the Charger provides the charge for recharging the CLS battery, it
is important to start the charging session with a full Charger battery.
If the charge falls to one bar, recharge the Charger.
Note: Always recharge the Charger at the end of each CLS charging session to
ensure you start the next charging session with a full Charger.
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CLS Battery Level indicator.
The CLS Battery Level’ indicator shows how much charge is left in the CLS. Note: TheCLS Battery Level’ indicator should show four lit bars at the end
of each charging session.
Caution: When the CLS Battery Level’ indicator shows one bar you should recharge the CLS battery as soon as you can. If you do not charge the CLS battery, the CLS will stop delivering therapy. Contact Clinician indicator. TheContact Clinician’ indicator will flash six times if the Charger detects
a problem with itself or the CLS. If the Contact Clinician’ indicator flashes, you need to contact your clinician so that they can investigate further. Note: TheContact Clinician’ indicator will not contact the
clinician on your behalf. It is a message to inform you that you should
contact your clinician during regular business hours.
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8.2 Charging your Evoke CLS using the Evoke Charger.
Follow the steps below to recharge your CLS:
Figure 8.2: An example of positioning the Charger coil over the implant. Place
Charger and Charger coil over clothing or in the Accessory Belt to ensure no
extended contact with your
skin. Note: Your implant may be in a different location in your body.
1. Turn therapy off using the EPC (refer to Section 7).
2. Unplug the Charger from the power adapter.
3. Hold the Charger coil over the CLS (refer to Figure 8.2). You may place
the Charger coil into the Accessory Belt pouch to hold the coil in place (see
Section 9.2).
4. Place Charger and Charger coil over clothing or fabric to ensure no
extended contact with your skin.
5. Press
for more than one second.
6. The Charger will beep every second until the coil starts to align with the CLS.
The `Charging Link’ indicator will then show at least two bars.
7. Move the Charger coil until the link is strongest. The `Charging Link’ indicator should then show three or four bars.
8. Keep the Charger coil in place over the CLS.
9. Do not wear the Charger coil on your skin for an extended time. Place clothing or the Accessory Belt between your skin and the Charger coil.
10. You may turn therapy on using the EPC once charging has started.
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11. The Charger will beep once if the Charger coil moves out of charging
range. Realign the Charger coil so the Charging Link’ indicator shows three or four bars. 12\. When charging is complete, the Charger will emit a long beep (one second). It will display four bars on theCLS Battery Level’ indicator for 10
seconds.
Caution: Turn therapy off before you start charging. You may experience
increases or decreases in therapy strength if you start charging while therapy
is on. You may turn therapy on once charging has started. However, closed-loop
stimulation is disabled during charging. You may experience increases or
decreases in therapy strength. In some cases, the therapy may stop during
charging.
Caution: When the orange bar on the Stimulator Battery Level’ indicator on the EPC is displayed, you should charge the CLS. Your stimulator will turn off and you will not receive therapy if the battery level gets too low. If the stimulator turns off, you should charge the CLS as soon as possible. Note: You must unlock the EPC before theStimulator Battery Level’ indicator
will show.
8.3 Charger audio indicators.
In addition to its visual indicators, the Charger will beep to indicate
various functions:
A short beep will occur every time you press a button.
A long (one second) beep indicates that the charge session is complete. All
the bars glow on the CLS Battery Level’ indicator for 10 seconds. A long (one second) beep indicates that the charge session was aborted by the user. The battery level indicator does not show. Three beeps indicates that the charge session has been aborted. The visual indicator show the reason why: o One bar glowing on theCharger Battery Level’ indicator shows that Charger
battery is too depleted to charge your CLS. Recharge the Charger before use
(refer to Section 8.4).
o One orange bar glowing on the Charger Link’ indicator for 10 seconds indicates a poor charge link. o TheContact Clinician’ indicator flashing on and off six times indicates a
problem. You should contact your clinician to resolve the issue.
8.4 Recharging your Evoke Charger.
Follow the steps below to charge your Evoke Charger:
1. If charging, remove the Charger coil from over the CLS.
2. Plug the power adapter into a power outlet.
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Caution: Be sure to plug the power adapter into a power outlet that is easy to
access. 3. Connect the Charger to the power adapter. 4. The Charger battery
level indicator will flash one to four bars every second while recharging the
Charger. 5. When recharge is complete, the Charger will beep, and the Charger Battery Level’ indicator will show four full bars (refer to Section 8.2 Charger Battery Level indicator’).
Caution: Do not leave the Charger power adapter plugged into a power outlet
after recharging is complete.
Caution: You cannot recharge your Charger while you are using it to charge the
CLS. You must remove the power adapter from the Charger before using it to
charge your CLS.
9 The Evoke Accessory Belt.
9.1 Wearing the eCLS with the Accessory Belt.
During the trial stimulation period, you may wear an Accessory Belt to hold
the eCLS. Place the eCLS into the Accessory belt using the following steps.
1. Place eCLS into the Accessory Belt pouch with the leads exiting the pouch
at the top (Figure 9.1).
2. Close the pouch by pressing the Velcro sides together. The Velcro will
fasten around the leads exiting the pouch.
3. Wrap the elasticated portion of the belt around your waist. Attach its
Velcro end to either the pouch or the belt itself. The belt should fit
comfortably and securely around your waist.
4. Position the belt so that there is no pulling or tension between the eCLS
and the leads. 5. To remove the Accessory Belt, hold the pouch and lift the
Velcro on the elasticated belt
to separate it from the pouch or belt.
Caution: To avoid pulling or tension between the eCLS and the leads, the belt
should not be moved during the trial (see Section 5 `
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Temporary trial stimulation’). Please contact your clinician if you need to
adjust the eCLS or belt.
Figure 9.1: Inserting the eCLS into the Accessory Belt.
9.2 Wearing the Charger Coil with the Accessory Belt.
The Accessory Belt can be used to hold the Charger coil in position when you
are charging your CLS. Follow the steps below to use the Accessory Belt with
your Charger:
1. Place the Charger coil into pouch of Accessory Belt with cable exiting the
pouch at the top (Figure 9.2).
2. Close the pouch by pressing the Velcro sides together. The Velcro will
fasten around the cable or leads exiting the pouch.
3. Wrap the elasticated portion of the belt around your waist. Attach its
Velcro end to either the pouch or the belt itself. The belt should fit
comfortably and securely around your waist.
4. Follow the Charger instructions (see Section 8.2) to charge the CLS.
5. Adjust the belt position if you need to re-align the Charge coil to the
CLS.
6. When finished charging, remove the Accessory Belt. Hold the pouch and lift
the Velcro on the elasticated belt to separate it from the pouch or belt.
7. The Accessory Belt is a re-usable item and may be machine washed at low
temperature.
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Figure 9.2: Inserting the Charger coil into the Accessory Belt.
10 Maintenance of EPC, Charger and eCLS.
You can wipe the parts periodically with a soft cloth dampened with water,
alcohol or a mild detergent solution. Do not use abrasive cleaners. Avoid
wiping the connectors on the Charger and eCLS, if applicable. DO NOT STERILIZE
the eCLS, EPC or Charger. These items are supplied non-sterile. Sterilization
could damage these devices beyond repair. You may be unable to use your
stimulation system. Contact your clinician for troubleshooting or possible
replacement if your device is not function as expected.
11 Disposal of devices.
Caution: Your eCLS, EPC and Charger contain batteries that could explode if
they are placed into a fire. The eCLS, EPC and Charger must not be discarded
in the normal municipal waste. Please return to Saluda Medical for disposal
via your clinical team.
12 Patient ID Card.
Every CLS is supplied with a Patient ID card for the clinician to complete and
give to you.
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Keep this card some place safe, as you may need it to show to doctors or
nurses who you see for other reasons. This is so they understand you have an
SCS system implanted. You may also need to show security personnel in shops or
airports if the implant triggers detectors.
Importantly, your Patient ID card will tell medical staff that you cannot have
an MRI scan. If you move, change physician, or lose your card, contact your
clinician for a replacement card.
13 Troubleshooting.
If you are experiencing problems with your system refer to the suggestions
below and contact your clinical team.
Table 13-1: Troubleshooting.
Issue
The `Contact Clinician’ indicator on my EPC or Charger is glowing.
Resolution
The stimulator has detected a problem that requires you to visit your
Clinician for assessment. Please contact your clinical team at your first
opportunity and remember to take your EPC and Charger with you.
Note: You will not be able to charge the stimulator if the `Contact Clinician’
indicator is flashing on your Charger.
During charging, my Charger beeps continuously.
The Charger will beep once per second when there is a poor link between the
Charger and the CLS.
Reposition the Charger coil over the implant so that the `Charging
My Charger started beeping during charging.
Charger will not turn on, or (during charging) beeped 3 times and turned off.
Link’ indicator shows at least 2 bars . Note: Wait about 1 second between each
reposition in order for the Charger to update the link.
The link between the Charger coil and your CLS has dropped below two bars so
charging is no longer possible. Adjust the position of the coil until the
Charging Link’ indicator displays at least two bars as shown above. Press and hold theStart Charging’ button for 2 seconds. If nothing happens,
or the Charger battery indicator is below 1 bar, plug the Charger into the
power adapter. Refer to Section 8.4.
Once the Charger battery indicator is full, disconnect from the power adapter
and try to charge again. Refer to Section 8.
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Issue
My EPC stimulation level indicator lights do not change when I increase or
decrease stimulation.
My therapy has stopped.
Resolution
Sometimes you will need to press the
or
button
multiple times before the lights will change. This is normal.
However, you should feel a change in stimulation intensity almost
every button press.
If you feel you need to be reprogrammed, please contact your clinical team.
The stimulator will stop stimulation if it detects an issue or if the stimulator battery is too low.
First try to restart your stimulator with your EPC. If the EPC does not connect to the stimulator, then refer to `Stimulator Battery too low’ below. If the EPC connects, but stimulation does not start, or it stops stimulation repeatedly, try the suggestions below.
If you have an eCLS 1. Stimulator battery too low:
a. Please contact your clinical team to organize battery recharge or
replacement.
2. Lead Disconnection: a. Do not open the eCLS Case. b. Please contact your
clinical team.
If you have a fully implanted CLS 1. Stimulator Battery too Low:
a. Place the Charger coil over the CLS and press the `Start Charging’ button
for 2 seconds.
b. If the CLS battery was low, then recharge it. Refer to Section 8. Then
restart stimulation. Refer to Section 7.
Stimulation strength becomes more variable.
This may happen during charging. It should resolve once charging is finished.
If this happens often when not charging, you should contact your Clinician to
reprogram your stimulator.
Stimulation strength suddenly decreases.
When the stimulation reaches some internal limits, it may decrease in strength automatically. You will be able to increase the strength again with your EPC. If this problem continues you may need to contact your Clinician to reprogram your stimulator.
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Issue The EPC will not turn on. My EPC does not appear to be working.
I cannot change programs.
Stimulation does not get stronger when you press the button .
Evoke® SCS System User Manual
Resolution
The batteries that power the EPC may have run low. Refer to Section 7.3 for
instructions on how to replace the batteries in the EPC.
If the stimulation is still on For help on performing any steps, refer to
Section 7. Ensure that the EPC is on when performing the steps below. 1. Low
battery:
a. If the EPC low battery indicator’ light is on you should change the batteries. 2\. EPC not communicating with the stimulator: a. Turn on the audio indicators (if they are off). b. Try to use the EPC again, if you hear 2 or 3 beeps this means the command is not getting through to the stimulator. c. Bring the EPC closer to the stimulator and try again. If you have a CLS, bring the EPC to the side where the CLS is implanted, or try to hold it directly behind the implant site. If the stimulation is off 1. SeeMy therapy has stopped’.
To change programs, you will have to press the
button
once (do not hold it). Then press it again while it is still flashing
until you select your desired program. Refer to Section 7.
If your program light does not change from Program 1 then you have only been given one program. Contact your clinical team if you think your stimulator needs to be reprogrammed.
When the stimulation reaches some internal limits, it will not increase. It may not show as 7 bars on the EPC. It may be fixed by changing posture or changing programs. If this continues you may need to contact your Clinician to reprogram your stimulator.
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14 Package contents.
Table 14-1: Package Contents.
Evoke Patient Controller (EPC) (Ref No: 3040)
Evoke Charger (Ref No: 3006) Evoke Accessory Belt (Ref No: 3039)
1 x Evoke Patient Controller (EPC) 2 x AAA Batteries 1 x Magnet
1 x Evoke Charger 1 x Evoke Power Adapter
1 x Evoke Accessory Belt
15 Technical Specifications.
15.1 Device Specifications.
15.1.1 Evoke CLS.
Table 15-1: Evoke CLS Specification.
Materials
Case Header Seals Connector springs Set screw
Titanium Epoxy Liquid silicone rubber Platinum Iridium (24 x connectors) Stainless steel
Dimensions Volume Weight Lead ports
68 mm x 48 mm x 12 mm (2.7 in x 1.9 in x 0.472 in)
33 cm³ (2 in³)
50 g (1.76 oz.)
2
Each lead or lead extension is secured by a set
screw at the port entry
Electrodes
25
Port 1: electrodes 1-12
Port 2: electrodes 13-24
CLS case is electrode 25 (recording only)
Stimulation parameters
Current Pulse Width Frequency
0 mA 50 mA (20 mA @750 ) 20 s 1000 s 10 Hz 1500 Hz
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Radio frequency communication
MICS band 8 channels*
Transmit/Receive Channel Bandwidth
402.45-405.55 MHz Centre frequency (MHz): 402.45, 402.75, 403.05, 403.35,
403.65, 403.95, 404.25, 404.55
300 kHz
Modulation type Frequency Shift Keying (FSK)
Range
1.0 m (3.3 ft.)
Effective Isotropic 25 µW (-16.02 dBm) maximum
Radiated Power (EIRP)
FCC ID
2AYGR-3042
*Channels are automatically selected when the communication session begins.
Battery
200 mAh Li-Ion rechargeable
Battery life
Greater than 10 years at moderate settings. (current = 5.0 mA, pulse width =
200 s, frequency = 60 Hz, impedance = 750 , 24hrs/day usage).
Greater than 10 years for more than 95% of patients.
*End of CLS Battery Life is defined by Saluda Medical as the point at which the device can no longer maintain enough charge to provide 24 hours of therapy. At higher or lower settings, this defined end of life could be shorter or longer respectively.
Charging
Transcutaneous charging using inductive coupling with an external coil
Implant depth
5 mm to 20 mm (0.2 in to 0.8 in)
Recording amplifier gain
Low: 250x High: 1000x
Data recording
32 MB, up to 1 year (Stimulation usage, ECAP amplitude and current statistics)
Radio opaque identifier
“SME BYY” Where “SME” is Saluda Medical, “B” is the CLS model and YY is the two-digit year of manufacture
Storage & Transportation Conditions
Temperature:
Min: -10 °C (14 °F) Max: 55 °C (131 °F)
Operating Conditions
Pressure:
70 kPa (0.69 atm) Max: 150 kPa (1.48 atm)
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15.1.2 Evoke eCLS (includes Case and Lead Adapters).
Table 15-2: Evoke eCLS Specification.
Materials
Dimensions Weight Electrodes Functional specifications Radio frequency
communication
eCLS body and case Case seal
ABS Plastic TPE
100 mm x 85 mm x 20 mm (3.9 in x 3.4 in x 0.8 in)
96 g (3.4 oz.)
24
Port 1: electrodes 1-12, Port 2: electrodes 13-24
All other functional specifications are the same as the CLS (See Section 15.1.1)
MICS band 8 channels*
402.45-405.55 MHz
Centre frequency (MHz): 402.45, 402.75, 403.05, 403.35, 403.65, 403.95,
404.25, 404.55
Transmit/Receive Channel Bandwidth 300 kHz
Modulation type Range
Frequency Shift Keying (FSK) 1.0 m (3.3 ft.)
Effective Isotropic Radiated
Power (EIRP)
FCC ID
25 µW (-16.02 dBm) maximum 2AYGR-3036
*Channels are automatically selected when the communication session begins.
Battery
800 mAh Li-ion rechargeable
Battery Life
Greater than 14 days between charges at moderate settings. Greater than 7 days between charges for more than 95% of patients.
Charging
Li-Ion battery charger
Ingress Protection eCLS in case
eCLS
IP22 Rating for protection against access of solid objects greater than or
equal to 12.5 mm, and for vertically dripping water when the device is tilted
15 degrees.
IP30 Rating for protection against solid objects greater than or equal to
2.5mm, and no protection against water.
IEC 60601-1 /
EN 60601-1 Classification
Type BF Applied Part Internally Powered Medical Electrical Equipment Continuous Operation
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Storage & Transportation Conditions
Operating Conditions
Evoke® SCS System User Manual
Temperature: Humidity: Pressure:
Temperature: Humidity: Pressure:
Min: -10 °C (14 °F) Min: 0% RH 70 kPa (0.69 atm)
Min: 5 °C (41 °F) Min: 15% RH 70 kPa (0.69 atm)
Max: 55 °C (131 °F) Max: 90% RH Max: 106kPa (1.05 atm)
Max: 40 °C (104 °F) Max: 90% RH Max: 106 kPa (1.05 atm)
15.1.3 Evoke Lead Adapters.
Table 15-3: Evoke Lead Adapters Specification
Materials
Body
ABS Plastic
Dimensions Lead connection
55 x 13 x 13 mm (2.2 x 0.5 x 0.5 in)
Ports
1
12 spring connectors Au plating on stainless steel
Lead Adapter to eCLS connection
12 pin plug
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15.1.4 Evoke CAP12 Percutaneous Lead (includes Trial Leads).
Table 15-4: Evoke CAP12 Percutaneous Lead Specification
Materials
Dimensions Electrodes
Connectors Storage & Transportation Conditions Operating Conditions
Lead body
Pellethane
Lead ends
Pellethane
Distal electrodes Platinum Iridium
Proximal connectors Platinum Iridium
Retention ring
MP35N1
Conductors
35N LT with Ag core (19 strand cable)
Lengths Diameter
60 cm (1.97 ft.) or 90 cm (2.95 ft.) 1.32 mm (0.05 in)
Number Length Pitch
12 3 mm (0.12 in) 7 mm (0.276 in)
Length Pitch
1.02 mm (0.040 in) 1.96 mm (0.077 in) center to center
Temperature:
Min: -10 °C (14 °F) Max: 55 °C (131 °F)
Pressure:
70 kPa (0.69 atm) Max: 150 kPa (1.48 atm)
1 Alloy of Nickel, Cobalt, Chromium and Molybdenum. MP35N is not in contact with tissue but may be in contact with body fluid.
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15.1.5 Evoke CAP12X Lead Extension.
Table 15-5: Evoke CAP12X Lead Extension Specification
Materials
Dimensions
Connectors
Storage & Transportation Conditions Operating Conditions
Lead extension body Pellethane
Lead extension ends Pellethane
Proximal connectors Platinum Iridium
Retention ring
MP35N1
Connector springs Platinum Iridium
Set screw
Titanium
Header body
Silicone
Lengths Body Diameter Header Length Header Diameter
55 cm (1.8 ft.) 1.32 mm (0.05 in) 41 mm (1.62 in) 5.23 mm (0.21 in)
Number Length Pitch
12 1.02 mm (0.040 in) 1.96 mm (0.077 in) center to center
Temperature:
Min: -10 °C (14 °F) Max: 55 °C (131 °F)
Pressure:
70 kPa (0.69 atm) Max: 150 kPa (1.48 atm)
1 Alloy of Nickel, Cobalt, Chromium and Molybdenum. MP35N is not in contact with tissue but may be in contact with body fluid.
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15.1.6 Evoke Anchors.
Table 15-6: Evoke Anchors Specification
Suture Anchor
Active Anchor
Form Material Diameter Length Form Materials
Diameter Length
Two suture eyelets
Silicone rubber
5 mm (0.20 in)
35 mm (1.38 in)
Three suture eyelets, and a set screw to secure the lead
Body Set screw Set Screw Block
Silicone rubber Titanium Titanium
5.4 mm (0.21 in)
35 mm (1.38 in)
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15.1.7 Evoke EPC.
Table 15-7: Evoke EPC Specification
Materials
Dimensions Weight Radio frequency communication
Body and Battery Cover
ABS Plastic
Buttons and Seal
TPE
Lens
Polycarbonate
90.4 mm x 49.9 mm x 24.5 mm (3.55 in x 1.96 in x 0.96 in)
73 g (2.56 oz)
MICS band 8 channels*
402.45-405.55 MHz
Centre frequency (MHz): 402.45, 402.75, 403.05, 403.35, 403.65, 403.95,
404.25, 404.55
Transmit/Receive Channel Bandwidth 300 kHz
Modulation type Range Effective Isotropic Power (EIRP) FCC ID
Frequency Shift Keying (FSK) 1.0 m (3.3 ft.) 25 µW (-16.02 dBm) maximum
2AYGR-3040
*Channels are automatically selected when the communication session begins.
Battery
2 x AAA Alkaline batteries. Approx. 2000mAh.
Battery Life
Greater than 60 days (dependent on usage)
Expected Service Greater than 1 year Life
Ingress Protection IP22 Rating for protection against access of solid objects greater than or equal to 12.5 mm, and for vertically dripping water when the device is tilted 15 degrees.
IEC 60601-1 /
EN 60601-1 Classification
Storage & Transportation Conditions
Operating Conditions
Type BF Applied Part
Internally Powered Medical Electrical Equipment
Continuous Operation
Temperature:
Min: -20 °C (-4 °F) Max: 60 °C (140 °F)
Humidity: Pressure: Temperature:
Min: 0% RH 70kPa (0.69 atm) Min: 5 °C (41 °F)
Max: 90% RH Max: 106 kPa (1.05 atm) Max: 40 °C (104 °F)
Humidity:
Min: 15% RH
Max: 90% RH
Pressure:
70 kPa (0.69 atm) Max: 106 kPa (1.05 atm)
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15.1.8 Evoke Charger.
Table 15-8: Evoke Charger Specification
Materials
Charger Control panel Charger coil
ABS Plastic PET Silicone
Dimensions
Charger Charge coil
139.7 mm x 82.6 mm x 26.2 mm (5.50 in x 3.25 in x 1.03 in)
Cable length
60 cm (2 ft)
Diameter
10 cm (3.9 in)
Thickness
7 mm (0.28 in)
Weight
410 g (14.48 oz)
Communication Inductive coupling Link
Battery
2 x 18650 Lithium ion protected cells. 5200 mAh
Charging
Via the supplied power adapter
Battery Life
Greater than 5 years at moderate settings Greater than 3 years for at least 95% of patients
- End of Charger battery life is 300 full charge and discharge cycles of the Charger battery.
Expected Service Greater than 1 year Life
Ingress Protection
IP22 Rating for protection against access of solid objects greater than or equal to 12.5 mm, and for vertically dripping water when the device is tilted 15 degrees.
IEC 60601-1 / EN 60601-1 Classification
Storage & Transportation Conditions
Operating Conditions
Type BF Applied Part
Internally Powered Medical Electrical Equipment
Continuous Operation
Temperature: Min: -20 °C (-4 °F)
Max: 60 °C (140 °F)
Humidity: Pressure: Temperature:
Min: 0% RH 70kPa (0.69 atm) Min: 5 °C (41 °F)
Max: 90% RH Max: 106 kPa (1.05 atm) Max: 30 °C (86 °F)
Humidity:
Min: 15% RH
Max: 90% RH
Pressure:
70 kPa (0.69 atm)
Max: 106 kPa (1.05 atm)
Supplied Power Input Voltage Adapter Rating Input Current
100-240 Vac, Class II Medical Electrical Equipment Max 0.3 A
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Note: Power adapter isolates the Charger from the mains power
Frequency
50 – 60 Hz
Output Voltage 8.4 Vdc
Output Current Max 1.3 A
Ingress Protection IP22 Rating
15.1.9 Evoke Accessory Belt.
Table 15-9: Evoke Accessory Belt Specification
Materials Dimensions
Belt Belt fastener Pouch front Pouch back Pouch fastener
Belt
Pouch
Elasticized poly/cotton Hook and loop fastener Brushed poly/cotton Perforated
nylon Hook and loop fastener
85 mm x 960 mm (3.3 in x 37.8 in) unstretched
140 mm x 270 mm (5.5 in x 10.6 in) unstretched
Storage Temperature Limitations
Low: -10 °C (14 °F) High: 55 °C (131 °F)
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15.2 Wireless Communication.
15.2.1 Quality of Service & Wireless Coexistence.
The Evoke SCS System employs a wireless communication link operating in the
402-405 MHz MICS frequency band. This band is designated for implantable
medical devices and enables communication between the CLS/eCLS and the EPC.
At the beginning of each communication session, the EPC automatically scans 8
channels in the frequency band and selects the least congested channel for
communication. All communication is error checked and is retried
automatically. The user is notified if the wireless communication link fails
to connect.
The communication range between the EPC and the CLS/eCLS is typically 1 m (3.3
feet). If you experience issues with the wireless communication between the
EPC and CLS/eCLS, try the following:
Hold the EPC closer to the CLS/eCLS.
Move away from other devices that may be causing interference (see Section
15.3).
Wait a few minutes and try connecting again.
Do not operate other wireless devices, such as a mobile phone, tablet or
laptop, at the same time.
15.2.2 Wireless Security.
The Evoke SCS System has a communication range of 1 m (3.3 feet). To enable
the EPC to communicate with an eCLS or CLS, it must first be paired with that
stimulator. The EPC may communicate with only one CLS or eCLS at a time. The
stimulator will not respond to any communication that does not come from a
paired device. Additional mechanisms are in place to safeguard the integrity
of the communication. There are no security settings that require input or
control by the user.
15.3 Electromagnetic Interference.
The following tables indicate the electromagnetic environment in which the
Evoke SCS System is intended to operate. This is to ensure compliance with
international standards for the electromagnetic interference (EMI) produced by
the Evoke SCS System or the susceptibility of the Evoke SCS System to EMI. For
more information on this section please contact a Saluda Representative.
Caution: Use of accessories, transducers, and cables other than those
specified or provided by the manufacturer of this equipment could result in
increased electromagnetic emissions or decreased electromagnetic immunity of
this equipment and result in improper operation.
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15.3.1 Guidance and Manufacturer’s Declarations.
Table 15-10 Electromagnetic emissions.
The Evoke SCS System is intended for use in the electromagnetic environment specified
below. The patient, doctor or any other user of the Evoke SCS System should ensure that it is
used in such an environment.
Emissions Test
Compliance
Electromagnetic environment guidance
Radiated disturbance, 30 MHz -6000 MHz CISPR 11 (EN 55011)
Group 1, Class B
The Evoke SCS System is unlikely to produce electromagnetic interference in nearby electronic equipment.
Conducted Emissions
0.15 MHz – 30 MHz CISPR 11 (EN 55011)
Harmonic emissions IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC 61000-3-3
Class B
Not applicable for the battery powered devices or device consuming less than
75 W from mains power outlet (Charger with power adapter) Not applicable for
the battery powered devices. Charger with power adapter complies with
requirements of the standard
The Evoke SCS System is suitable for use in all establishments, including domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes.
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Table 15-11 Electromagnetic immunity – electrostatic discharge and mains power.
The Evoke SCS System is intended for use in the electromagnetic environment specified
below. The patient, doctor or any other user of the Evoke SCS System should ensure that
it is used in such an environment.
Electromagnetic
Immunity Test IEC 60601 Test Level Compliance Level
environment
guidance
Electrostatic discharge (ESD) IEC 61000-4-2
± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air
±2 kV, ±4 kV, ±6 kV, ±8 kV contact ±2 kV, ±4 kV, ±8 kV, ±15 kV air
Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%
Electrical fast transient/burst IEC 61000-4-4
± 2 kV gaseous discharge at 100 kHz repetition frequency
± 2 kV @100 kHz repetition frequency for power supply lines to Charger power adapter.
Surge Immunity IEC 61000-4-5
± 0.5 kV, ± 1 kV
± 0.5 kV, ± 1 kV power supply line to Charger power adapter.
Mains power quality should be that of a typical household, commercial or
Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11
Voltage Dips: 0% residual voltage for 0.5 cycle at 0 °, 45 °, 90 °, 135 °, 180 °, 225 °, 270 °, 315 °; 0 % residual voltage; 1 cycle, and 70% residual voltage; 25/30 cycles Single phase: at 0 ° Voltage Interruptions:
Voltage Dips: 0% residual voltage for 0.5 cycle at 0 °, 45 °, 90 °, 135 °, 180 °, 225 °, 270 °, 315 °; 0% residual voltage for 1 cycle at 0 °; 70% residual voltage for 25 cycles at 0 °; Voltage Interruptions: 0% residual voltage for
hospital environment. If the user of the Charger power adapter requires continued operation during mains power interruptions, it is recommended that the Charger power adapter be powered from an uninterruptible power supply or a battery.
0% residual voltage;
250 cycles at 0 °;
250/300 cycles
Interval between Events min. 10s; Test cycle 3 times;
Power frequency
Power frequency (50/60 Hz) magnetic field IEC 61000-4-8
30 A/m 50/60 Hz
30 A/m
magnetic fields should be at levels characteristic of a typical location in a typical household, commercial or hospital environment.
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Table 15-12 Electromagnetic immunity radio frequency. The Evoke SCS System
is intended for use in the electromagnetic environment specified below. The
patient, doctor or any other user of the Evoke SCS System should ensure that
it is used in such an environment.
Caution: Portable and mobile RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer to any part of the Evoke SCS System, including cables, than the recommended separation distance stated below (0.3 m, 12 inches). Otherwise, degradation of the performance of this equipment could result.
Caution: Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
Immunity Test IEC 60601 Test Level Compliance Level
Electromagnetic environment guidance
Conducted RF IEC 61000-4-6
Radiated RF IEC 61000-4-3
Proximity fields from RF wireless communications equipment
3 Vrms 150 kHz to 80 MHz; 6 Vrms in ISM and amateur radio bands between 150
kHz and 80 MHz 80 % AM at 1 kHz
10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz
Up to 28 V/m at 0.3m at specified frequencies (refer Table 9, IEC 60601-1-2)
The Charger power adaptor functioned correctly during the test.
Not applicable for the battery-powered devices.
3 V/m for professional healthcare facility environment or 10 V/m for home
healthcare environment
Tested at up to 28 V/m, devices continued to function during test.
The separation distance between an interfering RF transmitter and any Evoke SCS should be greater than 0.3 m and the maximum power from the RF transmitter should not exceed 2W or 28 V/m at a distance of 0.3 m.
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15.4 Federal Communications Commission (FCC).
15.4.1 CLS, eCLS, EPC
This device complies with Part 15 of the FCC Rules. Operation is subject to
the following two conditions: (1) This device may not cause harmful
interference, and (2) this device must accept any interference received,
including interference that may cause undesired operation.
This equipment has been tested and found to comply with the limits for a Class
B digital device, pursuant to Part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to radio communications. However,
there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference to radio or
television reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one of the
following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and receiver.
Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
Consult the dealer or an experienced radio/TV technician for help.
FCC Caution: Any changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate this
equipment.
This transmitter must not be co-located or operating in conjunction with any
other antenna or transmitter.
The devices in the Evoke System may not interfere with stations operating in
the 400.150 406.000 MHz band in the Meteorological Aids, Meteorological
Satellite, and Earth Exploration Satellite Services and must accept any
interference received, including interference that may cause undesired
operation.
For MedRadio transmitters operating in the 401-406 MHz band, the following
statement applies:
This transmitter is authorized by rule under the Medical Device
Radiocommunication Service (in part 95 of the FCC Rules) and must not cause
harmful interference to stations operating in the 400.150-406.000 MHz band in
the Meteorological Aids (i.e., transmitters and receivers used to communicate
weather data), the Meteorological Satellite, or the Earth Exploration
Satellite Services and must accept interference that may be caused by such
stations, including interference that may cause undesired operation. This
transmitter shall be used only in accordance with the FCC Rules governing the
Medical Device Radiocommunication Service. Analog and digital voice
communications are prohibited. Although this transmitter
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has been approved by the Federal Communications Commission, there is no
guarantee that it will not receive interference or that any particular
transmission from this transmitter will be free from interference.
15.4.2 Charger
This device complies with Part 18 of the FCC Rules.
15.4.3 Radiation Exposure Statement.
The products comply with the FCC portable RF exposure limit set forth for an
uncontrolled environment and are safe for intended operation as described in
this manual.
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16 Glossary.
Evoke® SCS System User Manual
Table 16-1: Glossary. Term
Definition
Accessory Belt Charger
An elastic belt with a pouch to hold an eCLS or a Charger coil.
The device that charges the battery in the CLS.
Charger coil Charger Power Adapter
A circular paddle connected to the Charger that is held over the CLS to charge
the CLS battery.
The power supply adapter for the CLS/eCLS Charger.
Closed-Loop (CL) Stimulation
Closed-Loop Stimulator (CLS) Electrode Evoke Patient Controller (EPC) Evoked
Compound Action Potential (ECAP) External Closed-Loop Simulator (eCLS) Lead
Lead Adapter Lead Extension
Spinal Cord Stimulation (SCS) Stimulation
Stimulation that is automatically adjusted in response to measurements from
the spinal cord nerves (ECAP) to maintain stable therapy. This is also known
as ECAPcontrolled closed-loop stimulation.
An implantable pulse generator capable of ECAPcontrolled closed-loop
stimulation.
An electrical contact used to deliver stimulation current or to measure
responses from spinal cord nerves.
A remote control that allows the patient to adjust the therapy output from the
CLS/eCLS.
The electrical signal from multiple nerve fibers in response to an electrical
stimulus pulse.
The eCLS is a non-implantable device with the same functionalities as the CLS.
Insulated cable with exposed electrodes at the distal end used in
neurostimulation therapy.
An adapter to connect leads or lead extensions to the eCLS during the trial
stimulation period.
Insulated cable that is connected to a lead to increase its length. Also for
temporary use during the trial stimulation period.
A treatment for chronic pain using pulsed electrical signals delivered to the
spinal cord.
The application of electrical current through electrodes.
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17 Symbols.
Table 17-1: Symbols. Symbol
YYYY-MM-DD
YYYY-MM-DD
Evoke® SCS System User Manual
Definition Follow the instructions for use on this website:
www.saludamedical.com/manuals Follow the instructions for use Follow the
instructions for use at this website: www.saludamedical.com/manuals Symbols
Glossary can be found on this website: www.saludamedical.com/manuals/symbols
Catalogue number Serial number Lot number
Use by date (YYYY = year, MM = month, DD = day)
Caution
Temperature limitation (°F and °C) Manufacturer
Date of manufacture (YYYY = year, MM = month, DD = day)
Do not dispose of this product in the unsorted municipal waste stream
dispose of this product according to local regulations Type BF applied part
Non-ionizing electromagnetic radiation Do not use if package is damaged
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IP22 IP30
Evoke® SCS System User Manual
MR Unsafe. Not safe to use with MR imaging.
Ingress Protection Rating 22: Protected against access of solid foreign
objects greater
than or equal to 12.5mm diameter. Protected against vertically dripping water
when the device
is tilted 15 degrees. Ingress Protection Rating 30: Protected against solid
objects greater than or equal to
2.5mm, and no protection against water.
Class II Medical Electrical Equipment
Power supply connection
Serial Connection Caution: Federal law restricts this device to sale by or on
the order of a licensed healthcare practitioner
D101706 Rev 2.01
10 Jan 2022
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Evoke® SCS System User Manual
18 Contact us.
Most questions you have about your Evoke SCS System can be answered by reading this manual or looking at our website, www.saludamedical.com and/or www.saludamedical.com/manuals.
If you have any further questions, please email us at info@saludamedical.com.
Legal Manufacturer: Saluda Medical Pty Ltd 407 Pacific Highway Artarmon, NSW
2064 Australia
T +61 2 8405 8700
US Office: Saluda Medical Americas, Inc. 9401 James Ave S Suite 132
Bloomington MN, 55431 USA
T +1 952-491-4256
D101706 Rev 2.01
10 Jan 2022
Page 59 of 59
References
- Pioneers of Neuromodulation | Saluda Medical
- saludamedical.com/manuals
- saludamedical.com/manuals/symbols
Read User Manual Online (PDF format)
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