SALUDA MEDICAL Evoke Instructions for use

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 1 of 61
Evoke™ SCS System Clinical Manual
Use of the Evoke System including recommendations for
programming the Evoke Closed-Loop Stimulator (CLS) and the Evoke
External Closed-Loop Stimulator (eCLS)
For Clinical Trial Use Only
CAUTION –Investigational Device.
Limited by Federal (or United States) law to investigational use.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 2 of 61
Table of Contents
PRIVACY STATEMENT ......................................................................................................3
1DESCRIPTION ...........................................................................................................4
2INDICATIONS FOR USE .............................................................................................5
3CONTRAINDICATIONS ..............................................................................................5
4SAFETY INFORMATION.............................................................................................5
4.1 WARNINGS ....................................................................................................................5
4.2 PRECAUTIONS.................................................................................................................7
4.3 POTENTIAL RISKS ..........................................................................................................11
5INTRA-OPERATIVE PROGRAMMING WITH THE CI ...................................................12
5.1 CONFIRMATION OF OPTIMAL LEAD PLACEMENT ..................................................................12
5.2 CONFIRMATION OF PROPER CLS CONNECTION ...................................................................14
6POST-OPERATIVE PROCEDURES..............................................................................14
6.1 CONNECTING AN ECLS TO EXTERNALIZED LEADS .................................................................14
7CLINICAL PROGRAMMING - INTRODUCTION...........................................................18
7.1 CLINICAL INTERFACE (CI) ................................................................................................18
7.2 CLINICAL SYSTEM TRANSCEIVER (CST) ..............................................................................19
8CLINICAL PROGRAMMING –USING THE CPA ..........................................................19
8.1 PROGRAMMING OVERVIEW .............................................................................................19
8.2 CONNECTING THE CI TO THE CST AND ECLS/CLS ...............................................................20
8.3 SET STIMULATOR TIME ...................................................................................................22
8.4 RETRIEVE OR SET THE PATIENT ID AND PATIENT ZONE ..........................................................23
8.5 MEASURE ELECTRODE IMPEDANCE....................................................................................24
8.6 SET UP LEAD ORIENTATION ..............................................................................................25
8.7 CHOOSE THE STIMULATION ELECTRODES AUTOMATICALLY......................................................26
8.8 START AND STOP STIMULATION ........................................................................................27
8.9 SET UP ECAP MEASUREMENT..........................................................................................28
8.10 SET UP FEEDBACK CONTROL (FC) THERAPY.....................................................................30
8.11 ENABLE FEEDBACK CONTROL .......................................................................................31
8.12 SAVE A PROGRAM TO THE STIMULATOR .........................................................................31
8.13 INTERLEAVED STIMULATION.........................................................................................33
8.14 NEUROPHYSIOLOGICAL MEASUREMENTS........................................................................36
9CLINICAL INTERFACE –SETTINGS GUIDE .................................................................42
9.1 STIMULATION SETTINGS MENU........................................................................................42
9.2 MEASUREMENT AND FEEDBACK SETTINGS MENU................................................................42
9.3 ELECTRODE SELECTION MODES .........................................................................................43
9.4 CURRENT STEERING .......................................................................................................43
9.5 PATIENT PERCEPTION.....................................................................................................44
9.6 CLS MENU ..................................................................................................................45
9.7 NAVIGATION MENU ......................................................................................................46
9.8 SETTINGS MENU ...........................................................................................................47
9.9 ERROR DISPLAY ............................................................................................................48
10 OPERATION OF STIMULATOR WHEN ERRORS OCCUR .............................................49
10.1 OUT OF COMPLIANCE .................................................................................................49
10.2 REFERENCE CLOCK ERROR ...........................................................................................49
10.3 ELECTRODE DISCONNECTED .........................................................................................50
10.4 CURRENT AT MAXIMUM .............................................................................................50
10.5 ERT CLIPPING...........................................................................................................50

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 3 of 61
11 EVOKE POCKET CONSOLE AND EVOKE CHARGER ....................................................50
11.1 PAIR EPC TO STIMULATOR ..........................................................................................50
11.2 CLINICAL STUDIES –SET TREATMENT ARM .....................................................................51
12 EVOKE CHARGER....................................................................................................51
12.1 SAFE MODE ERROR ON CHARGER .................................................................................51
13 PATIENT ID CARD ...................................................................................................52
14 MAINTENANCE OF THE EVOKE CI AND EVOKE CST ..................................................52
14.1 MAINTENANCE OF THE EVOKE CI..................................................................................52
14.2 MAINTENANCE OF THE EVOKE CST ...............................................................................52
15 SPECIFICATIONS .....................................................................................................53
15.1 EVOKE CI .................................................................................................................53
15.2 EVOKE CST ..............................................................................................................53
15.3 EVOKE POCKET CONSOLE ............................................................................................54
15.4 EVOKE CHARGER .......................................................................................................54
15.5 EVOKE CLS ..............................................................................................................55
15.6 EVOKE ECLS.............................................................................................................56
15.7 EVOKE 12C PERCUTANEOUS LEAD ................................................................................56
16 SALUDA MEDICAL EVOKE SYSTEM LIMITED WARRANTY .........................................57
16.1 CLOSED-LOOP STIMULATOR ........................................................................................57
16.2 LEADS .....................................................................................................................57
16.3 EXTERNALS...............................................................................................................57
16.4 CLAIMS....................................................................................................................57
16.5 LIMITATIONS.............................................................................................................58
17 GLOSSARY AND SYMBOLS ......................................................................................59
17.1 GLOSSARY ................................................................................................................59
17.2 SYMBOLS .................................................................................................................60
18 CONTACT US ..........................................................................................................61
Trademarks
Saluda, Evoke and the Saluda Medical logo are either trademarks or registered trademarks
of Saluda Medical Pty Ltd.
Copyright statement
This work is copyright and may not be copied, reproduced or retransmitted without written
permission from Saluda Medical Pty Ltd.
Copyright © 2018 Saluda Medical Pty Ltd, Sydney, Australia. All rights reserved.
Privacy statement
Saluda Medical Pty Ltd has regulatory and statutory obligations to hold certain information
about its patients. This information will not be disclosed to third parties other than
regulatory, law enforcement bodies or other parties we are required to by law; our
subsidiaries and agents for the purpose of providing or promoting our goods and services,
and health insurers or funders for the purpose of resolving disputes or obtaining payment
for goods and services we provide.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 4 of 61
1Description
The Saluda™ Medical Evoke™ System is a Spinal Cord Stimulation (SCS) system that can
measure the Evoked Compound Action Potential (ECAP) and may provide consistent
stimulation based on the subject’s neural response during physiological changes and
movement by automatically adjusting the level of stimulation current required to meet the
subject’s requested target level.
The Evoke System may be used in conjunction with other pain management therapies, as
determined by the physician.
The Evoke System comprises several key components to deliver the therapy.
Table 1.1: Description of Evoke System components
Name: Evoke Closed-Loop Stimulator (CLS)
Catalogue Number: 0002, 2002
The Evoke Closed-Loop Stimulator (CLS) is a totally implanted spinal cord stimulator
that connects to the leads and is implanted under the skin for long-term therapy.
The CLS delivers stimulation through the leads and measures the neural response to
stimulation.
Name: Evoke External Closed-Loop Stimulator (eCLS)
Catalogue Number: 0020, 2020
During the trial stimulation period, the leads are connected to the Evoke External
Closed-Loop Stimulator (eCLS). The eCLS is an external stimulator worn during the
trial stimulation period. The eCLS delivers stimulation through the leads and
measures the neural response to stimulation.
Name: Evoke 12C Percutaneous Leads
Catalogue Number:
0008, 2008, 2026 (lead length 60 cm)
0016, 2016 (trial lead length 60 cm)
0009, 2009, 2027 (lead length 90 cm)
0017, 2017 (trial lead length 90 cm)
The Evoke 12C Percutaneous Leads are placed in the epidural space overlying the
spinal cord and are connected to an eCLS for a trial stimulation period or to a CLS for
long-term therapy.
One or two leads with 12 electrodes on each lead are implanted.
Name: Evoke Lead Adapter Kit
Catalogue Number: 2028
The Evoke Lead Adapter, Lead Adapter Cable and Lead Adapter Extension allow you
to connect the eCLS to the implanted leads.
Name: Evoke Pocket Console (EPC)
Catalogue Number: 0003, 2003
The Evoke Pocket Console (EPC) allows the patient to control their therapy and
actively monitors Stimulator battery status and other elements of the system. The
EPC and the Stimulator communicate with each other wirelessly.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 5 of 61
Name: Evoke Charger
Catalogue Number: 0006, 2006
The Evoke Charger allows you to recharge the battery in a CLS. The Charging coil
(attached to the Charger) is placed over the CLS and the charge is transferred
through the skin from the Charger to the CLS.
The Charger kit also includes a power adapter for recharging the Charger.
Name: Evoke Clinical Interface (CI)
Catalogue Number: 0024, 2024
The Evoke Clinical Interface (CI) is a tablet computer with a programming application
used by the clinician to adjust the therapy settings in the Evoke CLS or Evoke eCLS.
Name: Clinical System Transceiver (CST)
Catalogue Number: 0004, 2004
The Clinical System Transceiver (CST) is a plug in device (USB connection) that
enables exchange of information wirelessly between the CI and the stimulator.
2Indications for Use
The Saluda Medical Evoke SCS System is indicated as an aid in the management of chronic
intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated
with the following: failed back surgery syndrome, intractable low back pain and leg pain.
3Contraindications
Patient must be advised of the following contraindications:
The Evoke system must not be used in children under 18 years-old.
The Evoke system must not be used in patients who are pregnant.
4Safety Information
Patients must be advised of the following warnings and precautions.
4.1 Warnings
Diathermy
Patients implanted with the Evoke System should not be subjected to shortwave,
microwave and/or therapeutic ultrasound diathermy.
Diathermy generates energy that may cause heating at the percutaneous lead site
resulting in damage to the CLS, tissue damage, severe injury or death.
Magnetic Resonance Imaging (MRI)
As the Evoke System has not been tested for MRI compatibility, it is considered MRI
unsafe.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 6 of 61
Patients implanted with the Evoke System should not be subjected to MRI as it may
result in significant heating and/or tissue damage.
MRI exposure can damage the CLS, potentially requiring device explantation and
replacement.
MRI exposure may also induce voltages through the leads and stimulator leading to
unintended stimulation, such as tingling, shocking, or jolting.
CT Scans
Patients implanted with the Evoke System may experience a momentary increase in
stimulation when receiving a CT scan. Some patients have described this as
uncomfortable stimulation, jolting or a shocking sensation.
Prior to a patient undergoing a CT scan, turn the CLS off.
Electrosurgery
Patients implanted with the Evoke System should not be subjected to
electrosurgical techniques, such as electrocautery, in close proximity to the Evoke
system components.
oElectrosurgical devices generate energy that may cause tissue damage at the
lead site and result in severe injury.
oDamage may also occur to the CLS.
Interference with implanted cardiac devices
The Evoke System may interfere with other implanted stimulators with sensing
capabilities such as demand type pacemakers or cardioverter defibrillators.
The effects of implanted stimulation devices on the Evoke System is unknown.
Stimulator damage
If the CLS case is ruptured or pierced, then patient tissue may be exposed to battery
chemicals, which could lead to burns or tissue damage.
oDo not implant the CLS if the case is damaged.
Electromagnetic interference
Strong electromagnetic fields may turn the stimulator off, cause uncomfortable or
jolting stimulation or affect communication with the EPC.
Patients should be advised to avoid or turn stimulation off around:
oSecurity screeners such as those used at of department stores, public
buildings, and airports –patients should present their implantable device ID
card and request to go around the screener; but if they are required to go
through the screener they should turn stimulation off.
oPower lines or power generators.
oElectric steel furnaces and arc welders.
oLarge, magnetized stereo speakers.
oTag deactivators such as those found in retail stores and libraries.
Heat due to charging

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 7 of 61
During charging, the Charger and/or CLS may become warm.
Patients should not charge while sleeping or with the charging coil in contact with
their skin for prolonged periods as this may result in heating that can cause redness,
skin irritation or a burn.
If patients experience pain or discomfort, they should cease charging and contact
Saluda Medical.
Notification of an implanted stimulator prior to any other surgical procedures
Some surgical procedures that use electrical current could affect the patient’s
implanted stimulator and leads, cause serious injury, and may damage the
stimulator
Patients should be advised to inform their clinician prior to any procedure that they
have an implanted stimulator so the procedure can be conducted without using
electric current near the implanted stimulator or leads.
4.2 Precautions
Physician training
Implanting physicians should be trained in spinal cord stimulation (SCS) procedures.
Physicians should review the Evoke SCS System Surgical Guide before surgery.
Medical therapies
When used in close proximity to the Evoke System, the following medical therapies may
turn stimulation off or cause damage to the CLS:
Lithotripsy
Electrocautery
External defibrillation
Radiation therapy (any damage to the device by radiation may not be immediately
detectable).
Ultrasonic scanning
High-output ultrasound
TENS
Psychotherapeutic procedures (e.g. electroconvulsive therapy, transcranial
magnetic stimulation).
Laser procedures
If the patient is required to undergo these therapies:
1. Turn off stimulation.
2. Disconnect the eCLS if one is in use
3. Ensure all fields, electrodes, probes and/or ground plates are as far away as
possible from the Evoke System.
4. Use the lowest energy setting needed for the therapy.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 8 of 61
5. Check the functioning of the Evoke System after the procedure and contact Saluda
Medical if any problems are apparent.
6. For electrocautery, use bipolar mode if available.
Operating equipment
Patients may be distracted from operation of equipment if there are sudden
stimulation changes.
Patients should turn stimulation off before operating automobiles, other vehicles,
or potentially dangerous equipment.
Post-operative patient instructions
After implant of the Evoke System, patients should take care to allow adequate healing and
ensure that the leads and CLS do not move.
For six to eight weeks after surgery, patients should avoid:
olifting more than 2.2 kg (5 lbs);
ophysical activities requiring stretching, bending or twisting;
oraising their arms above their head.
Patients may experience temporary pain at the implant site as the incisions heal
after the surgery.
Patients may experience redness or irritation at the implant site, in which case they
should contact their physician to check the wound for infection or adverse reaction
to the implanted materials.
Stimulator manipulation
Patients should avoid manipulating the Evoke System through the skin as it may
cause damage, lead or CLS movement, pain, irritation, or skin erosion.
If the CLS is “flipped” over inside the skin pocket it may no longer be able to be
charged.
Scuba diving
Patients should always obtain advice from their clinician prior to any diving
activities.
Patients should not dive below 5 m (16 ft.) or use hyperbaric chambers above 150
kPa (1.5 atm).
The CLS may be damaged at greater depths or pressures.
Implant failure
It is possible for the stimulator to stop working due to failure of a component or
battery, or a broken wire.
Patients should be advised to charge their stimulator fully and, if it still fails to work,
contact the Clinician.
Sterilization and storage
All surgical and implantable components of the Evoke System are supplied sterile.
The sterilized components of the Evoke System are sterilized using ethylene oxide.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 9 of 61
All Evoke sterilized components are single use only and should not be re-sterilized
or reused, because of the risk of infection and device malfunction.
Please observe the storage conditions printed on the labels of each component –
particularly storage and transport temperature, which varies between components
–as inadequate storage could have a negative impact on shelf-life and sterility.
Please observe the expiration dates printed on the labels and return any expired
product to Saluda Medical because of the risk of infection.
If the packaging appears to be damaged, please return it to Saluda Medical for
replacement.
Patients should be advised to avoid storing the Evoke external accessories outside
the labeled temperature ranges or in steamy environments such as bathrooms and
to keep them dry.
Handling of the eCLS, EPC and Charger
Patients should be advised to carry and hold their accessories carefully to protect
them from striking hard surfaces or being dropped.
Patients should be advised to keep their accessories dry and never immerse them in
water.
Patients should be advised to not plug the Charger into outlets that are in humid
environments –such as a bathroom –or near water.
If patients need to clean their accessories, refer them to the Evoke Instructions for
Use.
Avoid prolonged skin contact of the external system components (lead adapter,
lead adapter cable, lead adapter extension, eCLS, EPC and Charger and charging
coil). Place clothing or dressings between skin and external system components.
Disposal of the stimulator, EPC and Charger
The CLS, eCLS, EPC and Charger contain batteries that could explode if they are
thrown into a fire.
The CLS, eCLS, EPC and Charger should be returned to Saluda Medical.
Disposal of sharps and explanted implants
Please dispose of any sharps and medical waste according to your usual procedures.
If you have explanted any component of an Evoke System for any reason please
contact Saluda Medical to arrange for its return.
Modifications to components
The components of the Evoke System are not intended to be modified by users or
surgeons in any way.
4.2.1 Unsupported software applications
Do not load software applications onto the Evoke CI. The Evoke CI has all the necessary
software required to interact with and program the Evoke SCS System from Saluda
Medical. Other applications could interfere in unpredictable ways with the programming

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 10 of 61
software installed and affect the delivery of therapy for patients. Any required software
installations shall be supported directly by Saluda Medical representatives or via detailed
instructions concerning specific installations as required.
4.2.2 Unsupported hardware
Do not connect any device to the Evoke CI other than the supplied: keyboard, charger
and Evoke CST. Do not connect the Evoke CST to any device other than a Saluda Medical
supplied Evoke CI. Unsupported hardware could interfere in unpredictable ways with the
programming software installed and affect the delivery of therapy for patients.
For data file extraction it is permissible to use an external memory stick that has passed a
screening check by an up-to-date anti-virus software application, but no files should be
transferred onto the CI unless otherwise instructed by Saluda Medical to do so.
4.2.3 Shared IT networks
Network connection is only permitted to secure networks. Connecting to unsecure
networks could lead to the modification of CI System or software that interfere in
unpredictable ways with the programming software installed and affect the delivery of
therapy for patients.
4.2.4 Modification of the programming software
Do not attempt to modify the Clinical Programming Application (CPA) software which
comes preinstalled on the CI for the programming of Saluda Medical neurostimulators. Any
deletion or modification of files associated with the CPA could adversely affect the
system's ability to effectively adjust therapy for patients.
Required software upgrades will be supported directly by Saluda Medical representatives
or via detailed instructions concerning specific upgrades as required. Additionally, any
stimulator software upgrades will be fully supported by Saluda Medical representatives –
do not attempt to modify the stimulator software without Saluda Medical’s instruction.
4.2.5 Non-sterile components
DO NOT STERILIZE either the CI or CST; these items are not to be sterilized and doing so
could irrevocably damage the devices.
4.2.6 Clinical staff training
Clinical staff using the CI/CST to program the Evoke SCS System must be adequately
trained in the programming of SCS systems generally. Additionally, clinical staff
programming the Evoke SCS System should have read the instructions within this manual. A
poor understanding of the programming of SCS systems generally and the Evoke System
specifically could cause unpleasant or painful stimuli for patients.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 11 of 61
4.2.7 Electromagnetic interference (EMI)
As the CI communicates via the CST to the neurostimulator (eCLS or CLS) wirelessly, the
quality of this connection can be adversely affected by some types of electrical equipment
that generate EMI. Such equipment should be avoided where possible when programming
and/or suspected if communication between stimulator and CI/CST is poor. Examples of
such equipment found in clinical environments include but are not limited to: Mobile
phones, electro-surgery tools, electromagnets, radiofrequency identification devices and
emergency vehicle/services radios.
4.2.8 General precautions for the CI
The CI is a critical piece of equipment to enable the delivery of therapy. Always handle it
with care and regularly inspect the device for damage and/or impaired functioning. Never
modify the CI in any way. If you have concerns about the integrity of the CI/CST contact
Saluda Medical representatives to arrange repair or replacement. The CI runs on a
rechargeable battery and can be used wirelessly or whilst plugged in via the power adapter
supplied. Care should be taken to keep the CI well charged so it can be used in clinical
environments where plug sockets are not readily available. Always have a spare charged CI
available in case of malfunction.
4.3 Potential Risks
Every surgery involves potential risks, including death. In addition to these surgical risks,
the risks associated with the implantation and use of a spinal cord stimulation system
include:
Undesirable changes in stimulation sensation and/or location.
Uncomfortable changes in stimulation (over and/or under stimulation).
Persistent post-surgical pain at hardware implantation sites.
CLS migration, which may result in pain or difficulty in charging.
Seroma or hematoma at surgery sites.
Epidural hemorrhage, spinal cord injury and possible paralysis.
Lead migration from the location chosen at initial implantation resulting in
stimulation changes.
Breakage of the lead or failure of other system components, which may result in
loss of stimulation.
Rejection of, or allergic reaction to, the implanted components.
Infection that may require hospitalization with intravenous antibiotic therapy.
Cerebrospinal fluid (CSF) leakage.
Inadequate pain relief following system implantation.
Erosion of the lead, or CLS through the skin.
Weakness, clumsiness, numbness or pain below the level of lead implantation.
Note: The patient may require surgery (including revision, explant and replacement) as a
result of any of the above.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 12 of 61
5Intra-Operative Programming with the CI
Note: The Evoke SCS System Surgical Guide provides specific information about surgical
procedures and necessary connections between leads/extensions/lead adapter/CLS/eCLS
as required for the various procedures.
Note: Neither the CI nor the CST are supplied sterile and should not be used inside the
sterile field during intra-operative programming; see Evoke SCS System Surgical Guide for
details.
5.1 Confirmation of Optimal Lead Placement
Physicians may have a preference on the method to confirm optimal lead placement in the
operating room. Lead position may be confirmed anatomically using fluoroscopy,
neurophysiologically using external neuromonitoring equipment, or ECAP measurement
and/or through paresthesia mapping using intraoperative patient feedback.
Following lead placement based on required anatomical location, the surgeon connects the
leads to the lead adapters and the lead adapters to the lead adapter cable and extension
inside the sterile field (see Evoke SCS System Surgical Guide for details). The surgeon passes
the end of the lead adapter extension out of the sterile field to the programming clinician.
5.1.1 Connect the lead adapter extension to the eCLS
This section is to be completed by the programming clinician outside of the sterile field.
1. Connect the lead adapter cable (or lead adapter extension) to the eCLS (refer to
Figure 5.1).
Figure 5.1: Connect the lead adapter cable (or lead adapter extension) to the eCLS.
5.1.2 Confirmation of optimal lead placement
Confirmation of optimal lead placement may use ECAP measurement (Section 5.1.2.1)
and/or paresthesia mapping (Section 5.1.2.2) to confirm medio-lateral lead location,
dermatomal coverage, ability to measure ECAPs, and/or paresthesia coverage of the
pain areas.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 13 of 61
5.1.2.1 ECAP measurement
This section is to be completed by the programming clinician outside of the sterile field.
Refer to Section 7 ‘Clinical Programming - Introduction’ for detailed programming
instructions.
1. Connect the CI to the eCLS.
2. Check electrode impedance using the CI to ensure the leads are connected properly
(see Section 8.5).
oIf electrode impedance is greater than 4000Ω check all the connections.
oCheck impedance after each reconnection of the proximal connector to the lead
adapter
3. Select the stimulation and measurement electrodes and settings.
4. Verify that an ECAP can be measured by stimulating, for example, at the top and
bottom of the lead
oIf the ECAP measured is not satisfactory, change the electrodes, stimulation or
measurement settings using the CI or move the percutaneous lead to a new
position.
oVerify ECAP measurement after changing settings or moving the percutaneous
lead.
5. When satisfied with the lead placement, turn stimulation off and disconnect the
eCLS from the lead adapter extension.
6. The surgeon then disconnects the lead adapter from the lead.
5.1.2.2 Paresthesia mapping
This section is to be completed by the programming clinician outside of the sterile field.
Refer to Section 8 ‘Clinical Programming ’ for detailed programming instructions.
1. Connect the CI to the eCLS.
2. Check electrode impedance using the CI to ensure the leads are connected properly
(see Section 8.5).
a. If electrode impedance is greater than 4000Ω check all the connections.
b. Check impedance after each reconnection of the proximal connector to the
adapter.
3. Select the stimulation and measurement electrodes and settings.
4. Increase stimulation current until the patient reports a medium level of paresthesia
(tingling).
5. Adjust settings to ensure that ECAPs are being measured correctly.
a. The patient should report paresthesia coverage of the body that aligns with
their pain area.
b. If paresthesia coverage is not satisfactory, change the electrode and
stimulation settings using the CI or move the percutaneous lead to a new
position.
6. Retest paresthesia coverage after changing settings or moving the percutaneous
lead.
7. When satisfied with the lead placement, turn stimulation off and disconnect the

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 14 of 61
eCLS from the lead adapter extension.
8. The surgeon then disconnects the lead adapter from the lead.
5.2 Confirmation of Proper CLS Connection
This task is only performed if a CLS is being implanted. The surgeon creates a pocket for
the CLS and tunnels the leads and/or extensions to the CLS pocket. The surgeon inserts the
proximal connector end of the leads and/or extensions into the ports in the header of the
CLS and places the CLS partially into the CLS pocket.
Programming clinician tasks:
1. Connect the CI to the CLS via the radio link (see Section 8.1).
2. Check electrode impedance using the CI to ensure the proximal connectors are
connected properly (see Section 8.1).
oIf electrode impedance is greater than 4000Ω check all the connections.
oCheck impedance after each reconnection of the proximal connector to the CLS
header block.
3. The surgeon tightens the set-screw on the CLS header when satisfied that there is a
proper connection.
oAlways check the impedance before tightening CLS header set-screw.
6Post-Operative Procedures
The stimulator (eCLS or CLS) can be programmed when the patient has recovered
sufficiently to interact with the programming clinician.
1. Train the patient on use of the EPC, eCLS or CLS and guidelines for recovery
after implant surgery (see Evoke SCS System User Manual).
2. If the patient has a CLS, also train them on correct use of the Evoke
System Charger (see Evoke SCS System User Manual).
3. If the patient has externalized leads for a temporary trial using an eCLS, go to
Section 6.1. (Connecting an eCLS to Externalized Leads).
4. If the patient has an implanted CLS, go to Section 7 ‘Clinical Programming -
Introduction’.
Caution: Aspects of the therapy may change with time due to lead movement or as
the patient becomes accustomed to the stimulation. You may reprogram the patient’s eCLS
or CLS if required at any time.
6.1 Connecting an eCLS to Externalized Leads
6.1.1 Connect the lead to the lead adapter
1. Place the tip of the proximal connector end of the lead into the end of the lead
adapter slot.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 15 of 61
Figure 6.1: Placing the tip of the proximal connector into the lead adapter slot.
2. Push the lead down into the slot completely using finger (see Figure 6.2), so that
the lead is flush with the top of the slot. The lead should not move when fully
pushed into the slot. After the lead is in the slot, press down again along its length
to ensure it is secure in the slot.
Figure 6.2: Pushing lead into slot.
3. Place the top cover of the lead adapter over the lead with the open side of the top
cover aligned with the lead adapter plug. Slide the top cover all the way onto the
lead adapter until the notch on the top cover clips into place (refer to Figure 6.3).

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 16 of 61
Figure 6.3: Placing the top cover over the lead and sliding onto lead adapter until it clips
into place.
4. Line up the end of the lead adapter plug with the end of the socket in the lead
adapter cable at an angle to ensure the connector pins do not get bent (Figure 6.4).
Push the lead adapter plug into the socket on the lead adapter cable until it clips
into place.
a. The lead adapter cable is labelled “1” on one side for electrodes 1-12 and
“2” on the other side for electrodes 13-24.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 17 of 61
Figure 6.4: Placing the lead adapter plug into the socket on the lead adapter cable.
5. To connect a second lead to the lead adapter repeat the above steps 1 to 4 (see
Figure 6.5).
Figure 6.5: Placing a second lead adapter into the lead adapter cable.
6.1.2 Connect the lead adapter cable to the lead adapter extension
Plug the lead adapter extension into the proximal connector of the lead adapter cable until
you feel a gentle click.
Note: use of a lead adapter extension is optional.
6.1.3 Connect the lead adapter cable or lead adapter extension to the
eCLS
Plug the lead adapter cable or lead adapter extension into the port on the eCLS until you
feel a gentle click (refer to Figure 6.6).

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 18 of 61
Figure 6.6: Connect the lead adapter cable or lead adapter extension to the eCLS.
Caution: Avoid prolonged skin contact of the lead adapter, lead adapter cable, lead
adapter extension and eCLS. Place clothing or dressings between skin and external system
components.
7Clinical Programming - Introduction
7.1 Clinical Interface (CI)
The CI is a Microsoft Surface Pro 4 tablet computer. Figure 7.1 shows basic physical
configuration. Full specifications for the tablet computer are available at
https://www.microsoft.com/surface/en-au/support/browse/surface-pro-4. The computer
is not physically modified in any way. The CI operates on the Microsoft Windows platform.
The CI is supplied with the software necessary for programming Saluda Medical stimulators
pre-installed, and no other software should be installed on the device.

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 19 of 61
Figure 7.1: Basic Physical Properties of CI.
Upon starting and logging in to the CI, the user will immediately find a program icon .
This will lead the user into the Clinical Programming Application (CPA) that enables
programming of either the Evoke eCLS or CLS.
Note: Login password for the CI will be provided by Saluda Medical representatives. Should
the CI operator or the CI operator’s organisation wish to change this password it is their
responsibility that all potential operators are aware of this password and can easily access
it should it be forgotten.
7.2 Clinical System Transceiver (CST)
The CST is a radio telemetry device that enables communication between the CI and the
stimulator (eCLS or CLS). Commands generated through the CPA loaded on the CI are sent
to the stimulator and data is received back from the stimulator to display in the CPA via the
CST. The CST is connected to the CI via a USB connector and receives power from the CI via
this link.
8Clinical Programming –Using the CPA
8.1 Programming overview
1. Test stimulation from several electrodes (see Section 8.7 and 8.8) and ask the
patient to report where they feel paresthesia.
2. Determine the stimulation electrodes that give the best paresthesia coverage of the
patient’s pain area.
3. Determine the settings that provide a good measurement of the neural response to
stimulation (ECAP –see Section 8.9).
On/Off Button
Touchscreen
Charging Port
Keyboard

Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 20 of 61
4. Determine the settings for optimum Feedback Control (FC) therapy (see Section
8.10).
5. Save the Program to the eCLS/CLS memory (see Section 8.12) and proceed to set up
a maximum of four programs.
6. Use the CPA with the eCLS/CLS to perform neurophysiological measurements of the
patient.
8.2 Connecting the CI to the CST and eCLS/CLS
To program and download data from the eCLS or CLS, communication must first be
established. The CST connects to the CI to communicate using a radio signal transmitted to
the eCLS or CLS.
1. Connect the CST to the CI with the USB connection (see Figure 8.1).
Figure 8.1: Connecting the CST to the CI
2. Position the CST near the stimulator and double-click the Evoke Clinical
Programming Application (CPA) icon to start the program (see Figure 8.2 for
the main screen layout).
Note: The CST can link with the stimulator within a 1.0 m (3.3 ft) radius.
Note: EMI can affect the quality of this wireless link, see Section 4 –Safety Information.