Related Manuals for SALUDA MEDICAL Evoke
Summary of Contents for SALUDA MEDICAL Evoke
- Page 1 Evoke™ SCS System User Manual Evoke SCS System Instructions for Use Document Reference: CLIN-UMAN-002426 Revision: 13.00 Page 1 of 48...
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Page 2: Table Of Contents
Table of Contents Description ......................... 5 Indications and contraindications ................6 Indications for use – What the Evoke System is used for ......... 6 Contraindications – When the Evoke System must not be used ....... 6 Safety information ...................... 6 Warnings ........................ - Page 3 Charging your Evoke CLS using the Evoke Charger ..........27 Charging your Evoke eCLS using the Evoke Charger ..........28 Charger audio indicators ..................28 Recharging your Evoke Charger ................28 Maintenance of EPC, Charger and eCLS ..............29 Disposal of devices ....................29 10 Patient ID Card ......................
- Page 4 Trademarks Saluda, Evoke, and the Saluda Medical logo are either trademarks or registered trademarks of Saluda Medical Pty Ltd. Copyright © 2019 Saluda Medical Pty Ltd, Sydney, Australia. All rights reserved. Refer to the Evoke SCS System MRI Guidelines for information on the safe use of the Evoke System in an MRI environment.
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Page 5: Description
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: •... -
Page 6: Indications And Contraindications
2 Indications and contraindications 2.1 Indications for use – What the Evoke System is used for The Saluda Medical Evoke System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs. 2.2 Contraindications – When the Evoke System must not be used The Evoke System must not be used in patients who: •... - Page 7 Evoke Charger and magnet) are MR Unsafe and must be removed before entering a room where an MRI scanner is located. • MRI scans that are not performed according to the Evoke SCS System MRI Guidelines may: o Cause significant heating resulting in tissue damage, severe injury, or death.
- Page 8 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 13.3). •...
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Page 9: Precautions
• 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. The Evoke System has not been tested for use in patients who are pregnant or nursing. - Page 10 • If you are charging the stimulator, Feedback Control mode is disabled, so you should turn stimulation off if charging while driving or operating equipment. • If you ever experience sudden changes in stimulation in Feedback Control mode, you should turn stimulation off before driving or operating equipment. In this case, you should contact the clinic to reprogram the Feedback Control mode settings in the stimulator.
- Page 11 Do not modify or tamper • Do not modify or tamper with your Evoke Pocket Console (EPC), your Evoke Charger or your external Closed Loop Stimulator (eCLS, if you have been given one). Modifying or tampering with your equipment could cause these items not to work at all, or to operate in an unpredictable way.
- Page 12 The eCLS and Charger are powered by internal rechargeable lithium ion batteries that you cannot replace. The eCLS is recharged wirelessly by the Charger. • Only use the power adapter supplied by Saluda Medical to recharge the Evoke Charger. • Do not touch the power adapter socket on the Charger.
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Page 13: Potential Risks Or Side Effects
4 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. -
Page 14: Percutaneous Lead Placement Procedure
• At the end of your trial stimulation period, your clinician will ask about the amount of pain relief you experienced with the Evoke System. Document Reference: CLIN-UMAN-002426 Revision: 13.00... -
Page 15: Lead Removal And Next Steps
• 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. -
Page 16: Ecls Battery
lead adapter extension on your skin for a prolonged time. Place clothing or dressing between your skin and these external parts. Ideally, you will leave the eCLS and leads connected to each other during the trial process. If you need to disconnect the eCLS for any reason: 1. -
Page 17: Fully Implantable Evoke System
If you have a successful trial stimulation period, you and your doctor may decide to proceed to a fully implanted Evoke System, which includes the CLS, 12C leads, lead extensions if required, the EPC and Charger. You should return your trial EPC, Charger (if applicable) and eCLS to your clinician. -
Page 18: How It Should Feel
5.3 How it should feel • Patients report that the feeling of using a stimulator ranges from nothing through to a tingling sensation. Caution: If you feel any uncomfortable sensations, such as shocks, jolts, burning, pain or cramping around the chest or abdomen, use your EPC to adjust the level of stimulation (refer to Section 6). -
Page 19: The Evoke Pocket Console (Epc)
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). Once charging has started you will be able to control the CLS with the EPC again (see Section 6). 6 The Evoke Pocket Console (EPC) Stop button Stimulator Battery... - Page 20 EPC On/Off button The ‘EPC On/Off’ button turns the EPC on and off. Turn the EPC off to lock the buttons from changing your therapy. Note: When you turn the EPC on, all of the lights will flash briefly. This is normal, and you should only pay attention to the lights that remain on.
- Page 21 ‘Increase Therapy’ button. Change Program button Press the ‘Change Program’ button to toggle between up to four different therapy programs stored in your Evoke CLS or Evoke eCLS. The currently selected program will glow on the ‘Selected Program’ indicators. 1. Press the ‘Change Program’ button once and the ‘Selected Program’...
- Page 22 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 shows that the stimulator has detected a problem that may require you to visit your clinician for assessment.
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Page 23: Epc Audio Indicators
• 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. -
Page 24: Changing The Battery In Your Epc
2. Gently open the back cover. 3. Remove the old batteries and insert new ones ensuring the battery terminals are placed in the correct orientation. 4. Replace the back cover and tighten the screw. 7 The Evoke Charger Charging Link indicator Contact Clinician... - Page 25 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.
- Page 26 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’...
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Page 27: Charging Your Evoke Cls Using The Evoke Charger
7.1 Charging your Evoke CLS using the Evoke Charger Follow the steps below to recharge your stimulator: Figure 7.2: An example of positioning the Charger coil over the implant. Place Charger coil over clothing to ensure no prolonged contact with your skin. Note: Your implant may be in a different location in your body. -
Page 28: Charging Your Evoke Ecls Using The Evoke Charger
Note: You must turn on the EPC before the ‘Stimulator Battery Level’ indicator illuminates. 7.2 Charging your Evoke eCLS using the Evoke Charger The battery in the eCLS may be recharged by following the same steps used to recharge the CLS battery (see Section 7.1). -
Page 29: Maintenance Of Epc, Charger And Ecls
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 7.1 Charger Battery Level indicator). -
Page 30: Troubleshooting
3 below 1 bar, plug the Charger into the power adapter times and turned (refer to Section 7 The Evoke Charger). Once the Charger battery indicator is full, disconnect from the power adapter and try to charge again (refer Section 7 The Evoke Charger). - Page 31 If you have an eCLS 1. Lead disconnection: a. Check that the stimulator is off by turning stimulation off with your EPC (refer to Section 6 The Evoke Pocket Console (EPC)). b. Check the connections between the lead adapter, lead adapter extension (if connected) and the eCLS.
- Page 32 My EPC does not If the stimulation is still on appear to be For help on performing any steps, refer to Section 6 The Evoke working Pocket Console (EPC). Ensure that the EPC is on when performing the steps below.
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Page 33: Package Contents
12 Package contents Table 12-1: Package Contents. Evoke Pocket Console (EPC) 1 x Evoke Pocket Console EPC (Ref No: 1003) 2 x AAA Batteries 1 x Magnet Evoke Charger 1 x Evoke Charger (Ref No: 1006 – EU;4006 – UK;5006 - AU) - Page 34 = 60 Hz, impedance = 750 Ω, 24hrs/day usage)* *End of Battery Life is defined by Saluda Medical as the point at which the device can no longer maintain enough charge to provide 24hrs of therapy. At higher or lower settings this defined end of life could be shorter or longer respectively.
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Page 35: Evoke Ecls
13.1.2 Evoke eCLS Table 13-2: 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.) Electrodes Port 1: electrodes 1-24... -
Page 36: Evoke 12C Percutaneous Lead (Includes Trial Leads)
13.1.3 Evoke 12C Percutaneous Lead (includes Trial Leads) Table 13-3: Evoke 12C Percutaneous Lead (includes Trial Leads). Materials Lead body Pellethane Lead ends Pellethane Distal electrodes Platinum Iridium Proximal connectors Platinum Iridium Retention ring MP35N Conductors 35N LT with Ag core... -
Page 37: Evoke 12C Lead Extension
13.1.4 Evoke 12C Lead Extension Table 13-4: Evoke Lead Extension. Materials Lead extension body Pellethane Lead extension ends Pellethane Proximal connectors Platinum Iridium Retention ring MP35N Connector springs Platinum Iridium Set screw Titanium Header body Silicone Dimensions Lengths 55 cm (1.8 ft.) Diameter 1.32 mm (0.05 in) - Page 38 Lead Adapter Ports Lead Adapter 12 pin socket per port Connection eCLS 28 pin plug Connection Lead Adapter Materials Plug / socket TPE Extension Cable Cable Length 1.5 m (4.9 ft.) Lead Adapter 28 pin socket Cable connection eCLS 28 pin plug connection Storage &...
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Page 39: Evoke Epc
13.1.6 Evoke EPC Table 13-6: Evoke EPC specifications. Materials ABS Plastic Dimensions 105 mm x 58 mm x 18.5 mm (4.13 in x 2.28 in x 0.73 in) Weight 88 g (3.1 oz) Radio frequency MICS band 402.45-405.55 MHz communication 8 channels* Centre frequency (MHz): 402.45, 402.75,... -
Page 40: Evoke Charger
13.1.7 Evoke Charger Table 13-7: Evoke Charger specifications. Materials Charger ABS Plastic Charger coil Silicone Dimensions 139.7 mm x 82.6 mm x 26.2 mm (5.50 in x 3.25 in x 1.03 in) Weight 410 g (14.48 oz) Communication Inductive coupling... -
Page 41: Wireless Communication
13.2.2 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. -
Page 42: Electromagnetic Interference
Table 13-8 Electromagnetic emissions The Evoke SCS System is intended for use in the electromagnetic environment specified below. The patient, doctor or any other user of Evoke SCS System should ensure that it is used in such an environment. Electromagnetic... - Page 43 Table 13-9 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 Evoke SCS System should ensure that it is used in such an environment.
- Page 44 Table 13-10 Electromagnetic immunity – radio frequency The Evoke SCS System is intended for use in the electromagnetic environment specified below. The doctor or the patient should ensure that it is used in such an environment. Portable and mobile RF communications equipment should be used no closer to any part of the Evoke SCS System, including cables, than the recommended separation distance stated below.
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Page 45: Glossary And Symbols
14 Glossary and symbols 14.1 Glossary Table 14-1: Glossary. Term Definition Charger The device that charges the battery in the CLS. Charger Power Adapter The power supply adapter for the CLS/eCLS Charger An implantable pulse generator capable of feedback Closed Loop Stimulator (CLS) control (aka closed-loop mode). - Page 46 Type BF applied part Non-ionising electromagnetic radiation Do not use if package is damaged MR Conditional: Refer medical staff to Evoke SCS System MRI Guidelines at http://www.saludamedical.com/manuals Ingress Protection Rating 22: • Protected against access of solid foreign objects greater IP22 than or equal to 12.5mm diameter.
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Page 47: Regulatory Statements
The CE Mark for the Evoke SCS System was first affixed in 2019. 16 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. - Page 48 Page 48 of 48 CLIN-UMAN-002426...