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Related Manuals for SALUDA MEDICAL Evoke SCS System
Summary of Contents for SALUDA MEDICAL Evoke SCS System
- Page 1 Evoke™ SCS System Surgical Guide Instructions for the use and implantation of the Evoke™ SCS System CAUTION – Investigational Device. Limited by Federal (or United States) law to investigational use. Document Reference: ENG-UMAN-000730 Revision: 6.00 Page 1 of 40...
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Page 2: Table Of Contents
Table of Contents DESCRIPTION ......................4 INTENDED USE ......................5 CONTRAINDICATIONS ....................5 SAFETY INFORMATION ....................6 ........................6 ARNINGS ........................8 RECAUTIONS ......................10 OTENTIAL ISKS PERCUTANEOUS LEAD IMPLANT PROCEDURE ............12 ........................12 VERVIEW ..................12 ERCUTANEOUS LACEMENT ANCHOR THE LEAD .................... - Page 3 YMBOLS 17 CONTACT US ......................40 Trademarks Saluda, Evoke™ and the Saluda logo are 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.
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Page 4: Description
1 Description The 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 subjects neural response during physiological changes and movement by automatically adjusting the level of stimulation current required to meet the subject’s requested target level. -
Page 5: Intended Use
4.5” needle supplied with the lead kits is too short to reach the epidural space. 2 Intended 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. -
Page 6: Safety Information
4 Safety Information Patients must be advised of the following warnings and precautions (sections 4.1 and 4.2): 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 lead site resulting in damage to the CLS, tissue damage, severe injury or death. - Page 7 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: o Security screeners such as those used at of department stores, public buildings, and airports –...
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Page 8: Precautions
4. Use the lowest energy setting needed for the therapy. 5. Check the functioning of the Evoke™ System after the procedure and contact Saluda Medical if any problems are apparent. 6. Use bipolar mode for electrical therapies if available Operating equipment •... - Page 9 • Please observe the expiration dates printed on the labels and return any expired product to Saluda Medical because of the risk of infection. Document Reference: ENG-UMAN-000730 Revision: 6.00...
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Page 10: Potential Risks
• 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. - Page 11 • 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.
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Page 12: Percutaneous Lead Implant Procedure
5 Percutaneous Lead Implant Procedure Overview Figure 5.1: Overview of the percutaneous lead implantation process Percutaneous Lead Placement Insert the epidural needle 1. Mark the patient’s back using fluoroscopy for the required vertebral level. Warning: The risk of patient injury increases as the needle insertion site moves up the spinal column from lumbar to cervical. - Page 13 Select an insertion site that provides the widest and easiest possible access to the epidural space to reduce the risk of patient injury due to spinal cord trauma. Caution: It is recommended that the patient remain communicative during needle and lead placement to help mitigate any risk of neural injury. 2.
- Page 14 Insert the percutaneous lead 1. Feed the percutaneous lead with the stylet, through the needle into the epidural space (refer to Figure 5.4). Figure 5.4: Feeding the percutaneous lead and stylet through the needle. Position the percutaneous lead 1. Use the Stylet handle to rotate and guide the percutaneous lead with one hand as you advance it with the other, while viewing it under fluoroscopy.
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Page 15: Anchor The Lead
The Evoke leads are compatible with the following anchors: 1. Saluda Medical Evoke™ Suture Anchor (provided with all lead kits). 2. Saluda Medical Evoke™ Active Anchor (provided with lead kits #0008 and 0009) 3. Medtronic Bi-Wing Injex® Anchor (Model 97792) 4. - Page 16 Caution: Do not use polypropylene sutures on the silicone anchor as the polypropylene may damage or cause it to fail. Evoke™ Active anchor 1. Fit the head of the torque wrench (Figure 6.2A) supplied in the lead kit into the setscrew in the active anchor (refer to Figure 6.2B).
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Page 17: Create A Strain Relief Loop In The Lead
Create a strain relief loop in the lead 1. Using blunt dissection, create a small subcutaneous pocket at the incision site for a small loop of lead. 2. Create a loop in the lead and insert into the small pocket to provide some slack to minimize tension on the lead due to body movement (refer to Figure 6.4). - Page 18 • For an intermediate incision point tunneling procedure (when the required tunnel is longer than the tunneling tool) proceed to section 7.2.2. Using a single tunneling pass Note: Two leads can be tunneled at the same time. 1. Create a pocket at the lead insertion site for the lead strain relief loop. 2.
- Page 19 Figure 7.2: Inserting the proximal connectors into the CLS header 3. Gently slide the proximal connector until it hits a stop. a. All contacts should be within the port. b. The end of the proximal connector should rest against the stop – visible through the header.
- Page 20 Figure 7.3: Tightening the port screws until you hear a "click". 7. If you are using only one lead, place the CLS port plug in the unused port to prevent moisture ingress (refer to Figure 7.4). Figure 7.4: Inserting the port plug. 8.
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Page 21: Anchor The Cls, Close And Dress The Incisions
Figure 7.5: Strain relief loop at the CLS port entry. Figure 7.6: Examples where the lead has been bent at the port of entry of the CLS header. Take care to avoid this when creating the strain relief loop. Anchor the CLS, close and dress the incisions 1. -
Page 22: Trial With A Temporary Percutaneous Lead
8 Trial with a Temporary Percutaneous Lead Note: After completing steps 5.2.1 to 5.2.4 proceed to section 8.1. Remove the stylet and epidural needle 1. Carefully withdraw the epidural needle from the insertion site by sliding it along the percutaneous lead until clear of the body. 2. -
Page 23: Open The Component Sites
Note: All explanted components should be returned to Saluda Medical for analysis. Refer to Saluda Contacts in the Contact Us section of this document (see Section 17 ‘Contact us’). Open the component sites 1. Turn stimulation off using the patient’s EPC. -
Page 24: Intra-Operative Testing
10 Intra-Operative Testing Place lead(s) based on required anatomical location. Connect the lead to the lead adapter Figure 10.1: Lead adapter kit. 1. Place the tip of the proximal connector end of the lead into the end of the lead adapter slot. -
Page 25: Document Reference: Eng-Uman
Figure 10.3: 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. -
Page 26: Connect The Lead Adapter Cable To The Lead Adapter Extension
4. Line up the end of 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. Push the lead adapter plug into the socket on the lead adapter cable until it clips into place. •... -
Page 27: Confirm Optimal Lead Placement
1. The programming clinician or Saluda Representative will plug the lead adapter extension into the port on the eCLS (refer to Figure 10.7). Figure 10.7: Connect the lead adapter cable (or lead adapter extension) to the eCLS. Confirm optimal lead placement •... -
Page 28: Disconnecting The Lead Adapter From The Lead Adapter Cable
Paresthesia mapping Refer to the Evoke™ Clinical Manual 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. o If electrode impedance is greater than 4000Ω check all the connections. o Check impedance after each reconnection of the proximal connector to the adapter. -
Page 29: Disconnect The Lead From The Lead Adapter
Figure 10.8: Disconnecting the lead adapter from the lead adapter cable. Figure 10.9: Lead steering with the lead adapter connected to the lead. Disconnect the lead from the lead adapter 1. When satisfied with the lead placement you may disconnect the lead adapter from the lead. -
Page 30: Sterilization
Figure 10.10: Removing the top cover and disconnecting the lead from the lead adapter. 11 Sterilization All items detailed in this document, with the exception of the eCLS, are provided sterile and are for single use only. None of these items should be re-sterilized or reused. Sterilization method is Ethylene Oxide. -
Page 31: Package Contents
14 Package Contents Table 14.1: Package contents Evoke™ Closed Loop Stimulator Kit (Ref. No.: 1 x Evoke™ Closed Loop Stimulator 0002) 1 x Evoke™ CLS Port Plug 1 x Torque Wrench Evoke™ External Closed Loop Stimulator 1 x Evoke™ External Closed Loop (Ref No.: 0020) Stimulator Evoke™... - Page 32 Evoke™ Spares Kit (Ref. No.: 0015) 2 x Evoke™ Suture Anchors 1 x Epidural Needle, 14 gauge, 11.3 cm (4.5 in) spoonbill type. 1 x Bent Stylet (15° angle) of 0.36 mm (0.014 in) diameter, compatible with 90 cm Percutaneous Lead. 1 x Straight Stylet of 0.36 mm (0.014 in) diameter, compatible with 90 cm Percutaneous Lead.
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Page 33: Specification
15 Specification Evoke™ CLS Table 15.1: Evoke™ CLS Materials Case Titanium Header Epoxy Seals Liquid silicone rubber Connector springs Platinum Iridium (24 x connectors) Set screw Stainless steel Dimensions 68 mm x 48 mm x 12 mm (2.7 in x 1.9 in x 0.472 in) Volume 33 cm³... -
Page 34: Evoke™ Ecls
Radio opaque “SME AYY” identifier Where “SME” is Saluda Medical, “A” is the CLS model and YY is the two-digit year of manufacture Evoke™ eCLS Table 15.2: Evoke™ eCLS Materials Case Nylon 12 Plug / socket Cable Dimensions 85 mm x 78 mm x 16 mm (3.35 in x 3.07 in x 0.63 in) Weight 124 g (4.4 oz.) -
Page 35: Evoke ™ 12C Percutaneous Lead ( Includes Trial Leads )
Evoke™ 12C Percutaneous Lead (includes trial leads) Table 15.3: Evoke™ Percutaneous Lead Materials Lead body Pellethane Lead ends Pellethane and Epoxy Distal electrodes Platinum Iridium Proximal connectors Platinum Iridium Retention ring MP35N Conductors MP35N with Ag core (19 strand cable) Dimensions Lengths 60 cm (1.97 ft.) or 90 cm (2.95 ft.) - Page 36 Dimensions Length 279.4 mm (11 in) Straw length 203.2 mm (8 in) Body diameter 4 mm (0.157 in) Straw ID 4.2 mm (0.166 in) Straw OD 5 mm (0.196 in) Torque Materials Handle Polyetherimide plastic Wrench Shaft Stainless steel Dimensions Length 40 mm (1.575 in) Bit size...
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Page 37: Evoke™ Ci Specifications
Lead Adapter 28 pin socket Cable connection eCLS 28 pin plug connection Evoke™ CI specifications Full specifications for the Clinical Interface hardware can be found in the Surface Pro 4 manual accessible at https://www.microsoft.com/surface/en-au/support/browse/surface- pro-4. Evoke™ CST specifications Table 15.5: Evoke™ CST specifications. Dimensions Length –... -
Page 38: Glossary And Symbols
16 Glossary and Symbols Glossary Table 16.1: Glossary Term Definition Charger The device that charges the battery in the CLS/eCLS The computer loaded with the CPA used to program the Clinical Interface (CI) CLS/eCLS Closed Loop Stimulator An implantable pulse generator capable of feedback (CLS) control (aka Closed-loop mode) Clinical System Transceiver... -
Page 39: Symbols
Date of manufacture (YYYY = year, MM = month, DD = day) YYYY-MM-DD Do not dispose of this product in the unsorted municipal waste stream – return to Saluda Medical for disposal Type BF applied part Non-ionizing electromagnetic radiation Do not use if package is damaged... -
Page 40: Contact Us
If you have any further questions, please contact your Saluda Medical field clinical engineer (FCE). Alternatively, you can contact us via the details below or email us at info@saludamedical.com.
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