Evoke® SCS System User Manual Instructions for the use of the Evoke SCS System D101706 Rev 2.
Evoke® SCS System User Manual Table of Contents 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. ...........................................................................................
Evoke® SCS System User Manual 9 8.3 Charger audio indicators............................................................................................... 33 8.4 Recharging your Evoke Charger. ................................................................................... 33 The Evoke Accessory Belt. ............................................................................................ 34 9.1 Wearing the eCLS with the Accessory Belt. ........................................................
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. D101706 Rev 2.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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).
Evoke® SCS System User Manual 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.).
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual Figure 5.4 eCLS with two leads connected enclosed in the eCLS case. D101706 Rev 2.
Evoke® SCS System User Manual 6 Fully implantable Evoke System. If you have a successful trial stimulation period, you and your doctor may decide to proceed to a fully implanted Evoke System. 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.
Evoke® SCS System User Manual 6.1.3.1 Using the EPC. 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.
Evoke® SCS System User Manual 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).
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual The ‘Therapy Intensity’ indicators will glow to reflect the level of your current therapy settings. You can change the level using the ‘Increase 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.
Evoke® SCS System User Manual EPC Low Battery indicator. 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.
Evoke® SCS System User Manual 7.2.1 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. 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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. The ‘Charging 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.
Evoke® SCS System User Manual CLS Battery Level indicator. The ‘CLS Battery Level’ indicator shows how much charge is left in the CLS. Note: The ‘CLS 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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 the ‘CLS 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.
Evoke® SCS System User Manual 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’).
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual Issue Resolution My EPC stimulation level indicator lights do not change when I increase or decrease stimulation. 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. My therapy has stopped.
Evoke® SCS System User Manual Issue Resolution The EPC will not turn on. 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. My EPC does not appear to be working. 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.
Evoke® SCS System User Manual 14 Package contents. Table 14-1: Package Contents. Evoke Patient Controller (EPC) (Ref No: 3040) 1 x Evoke Patient Controller (EPC) 2 x AAA Batteries 1 x Magnet Evoke Charger (Ref No: 3006) 1 x Evoke Charger 1 x Evoke Power Adapter Evoke Accessory Belt (Ref No: 3039) 1 x Evoke Accessory Belt 15 Technical Specifications. 15.1 Device Specifications. 15.1.1 Evoke CLS. Table 15-1: Evoke CLS Specification.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 15.1.2 Evoke eCLS (includes Case and Lead Adapters). Table 15-2: Evoke eCLS Specification. Materials eCLS body and case Case seal Dimensions 100 mm x 85 mm x 20 mm (3.9 in x 3.4 in x 0.8 in) Weight 96 g (3.4 oz.) Electrodes 24 Functional specifications All other functional specifications are the same as the CLS (See Section 15.1.1) Radio frequency communication MICS band 8 channels* ABS Plastic TPE Port 1: electrodes 1-12, Port 2: electrodes 13-24 402.45-405.
Evoke® SCS System User Manual Storage & Transportation Conditions Temperature: Humidity: Pressure: Min: -10 °C (14 °F) Min: 0% RH 70 kPa (0.69 atm) Max: 55 °C (131 °F) Max: 90% RH Max: 106kPa (1.05 atm) Operating Conditions Temperature: Humidity: Pressure: Min: 5 °C (41 °F) Min: 15% RH 70 kPa (0.69 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 Dimensions 55 x 13 x 13 mm (2.2 x 0.5 x 0.
Evoke® SCS System User Manual 15.1.4 Evoke CAP12 Percutaneous Lead (includes Trial Leads). Table 15-4: Evoke CAP12 Percutaneous Lead Specification Materials Lead body Lead ends Distal electrodes Proximal connectors Retention ring Conductors Pellethane Pellethane Platinum Iridium Platinum Iridium MP35N1 35N LT with Ag core (19 strand cable) Dimensions Lengths Diameter 60 cm (1.97 ft.) or 90 cm (2.95 ft.) 1.32 mm (0.05 in) Electrodes Number Length Pitch 12 3 mm (0.12 in) 7 mm (0.
Evoke® SCS System User Manual 15.1.5 Evoke CAP12X Lead Extension. Table 15-5: Evoke CAP12X Lead Extension Specification Materials Lead extension body Lead extension ends Proximal connectors Retention ring Connector springs Set screw Header body Pellethane Pellethane Platinum Iridium MP35N1 Platinum Iridium Titanium Silicone Dimensions 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) Connectors Number Length Pitch 12 1.02 mm (0.
Evoke® SCS System User Manual 15.1.6 Evoke Anchors. Table 15-6: Evoke Anchors Specification Suture Anchor Active Anchor D101706 Rev 2.01 Form Two suture eyelets Material Silicone rubber Diameter 5 mm (0.20 in) Length 35 mm (1.38 in) Form Three suture eyelets, and a set screw to secure the lead Materials Body Set screw Set Screw Block Diameter 5.4 mm (0.21 in) Length 35 mm (1.
Evoke® SCS System User Manual 15.1.7 Evoke EPC. Table 15-7: Evoke EPC Specification Materials Body and Battery Cover ABS Plastic Buttons and Seal TPE Lens Polycarbonate Dimensions 90.4 mm x 49.9 mm x 24.5 mm (3.55 in x 1.96 in x 0.96 in) Weight 73 g (2.56 oz) Radio frequency communication 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.
Evoke® SCS System User Manual 15.1.8 Evoke Charger. Table 15-8: Evoke Charger Specification Materials Charger Control panel Charger coil ABS Plastic PET Silicone Dimensions Charger 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) Charge coil Weight 410 g (14.48 oz) Communication Link Inductive coupling Battery 2 x 18650 Lithium ion protected cells.
Evoke® SCS System User Manual Note: Power adapter isolates the Charger from the mains power Frequency Output Voltage Output Current Ingress Protection 50 - 60 Hz 8.4 Vdc Max 1.3 A IP22 Rating 15.1.9 Evoke Accessory Belt. Table 15-9: Evoke Accessory Belt Specification Materials Belt Belt fastener Pouch front Pouch back Pouch fastener Elasticized poly/cotton Hook and loop fastener Brushed poly/cotton Perforated nylon Hook and loop fastener Dimensions Belt 85 mm x 960 mm (3.3 in x 37.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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. Electromagnetic environment Emissions Test Compliance – guidance Radiated disturbance, 30 MHz -6000 MHz CISPR 11 (EN 55011) Group 1, Class B Conducted Emissions 0.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 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.
Evoke® SCS System User Manual 16 Glossary. Table 16-1: Glossary. Term Definition Accessory Belt An elastic belt with a pouch to hold an eCLS or a Charger coil. Charger The device that charges the battery in the CLS. Charger coil A circular paddle connected to the Charger that is held over the CLS to charge the CLS battery. Charger Power Adapter The power supply adapter for the CLS/eCLS Charger.
Evoke® SCS System User Manual 17 Symbols. Table 17-1: Symbols. Symbol 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.
Evoke® SCS System User Manual MR Unsafe. Not safe to use with MR imaging. Ingress Protection Rating 22: IP22 IP30 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.
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 D101706 Rev 2.01 US Office: Saluda Medical Americas, Inc.
