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SALUDA MEDICAL Evoke SCS System, User Manual

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SALUDA MEDICAL Evoke SCS System User Manual Download Page 12

Evoke

® 

SCS System User Manual 

•

 

Only use the power adapter supplied by Saluda Medical to recharge the Charger. 

•

 

Do not touch the power adapter socket on the Charger. 

•

 

Do not leave the Charger power adapter plugged in after recharging is complete. 

The eCLS is powered by a rechargeable lithium ion battery that can be recharged or replaced 
only by your clinician or a Saluda Medical representative. 

•

 

Do not open the case of your eCLS, remove or tamper with the eCLS battery. 

•

 

Please contact your clinic for recharge or replacement of your eCLS battery. 

Disposal of your stimulator, EPC and Charger 

•

 

Your eCLS, EPC and Charger should be returned to your physician if you are no longer 
using them. 

•

 

Your eCLS, EPC and Charger contain batteries that could explode if they are thrown into 
a fire. 

4.3  Potential risks or side effects 

All medical procedures involve some risk of injury, including death. In addition, there may be 
risks associated with having a SCS system that are presently unknown or unforeseeable. Despite 
all reasonable precautions, you might develop medical complications from having a SCS system. 

Potential risks of implantation and use of a SCS system 

•

 

Undesirable changes in stimulation sensation and/or location. 

•

 

Uncomfortable changes in stimulation (over and/or under stimulation). 

•

 

Temporary or persistent post-surgical pain at hardware implantation sites. 

•

 

CLS migration or sub-optimal placement, which may result in pain or difficulty in 
charging. 

•

 

Seroma or hematoma at surgery sites. 

•

 

Epidural hemorrhage, spinal cord injury, possible paralysis or other neurological 
complications. 

•

 

Lead migration or sub-optimal placement, which may result in undesirable stimulation 
changes. 

•

 

Breakage of the lead, or malfunction or failure of other system components, which may 
result in undesirable changes or loss of stimulation. 

•

 

Allergic response or tissue reaction to the implanted or external materials. 

•

 

Infection that may require hospitalization with intravenous antibiotic therapy. 

•

 

Infection that may result in epidural abscess that can lead to neurological harm. 

•

 

Cerebrospinal fluid (CSF) leakage with possible fistula formation. 

CLIN-UMAN-005176 

Revision: 4.01 

Page 12 of 53 

Summary of Contents for Evoke SCS System

Page 1: ... saluda MEDICAL Rx Only Evoke SCS System User Manual Evoke SCS System User Manual Instructions for the use of the Evoke SCS System CLIN UMAN 005176 Revision 4 01 Page 1 of 53 ...

Page 2: ...4 5 3 How it should feel 14 5 4 Lead or lead extension removal and next steps 14 5 5 The eCLS 15 6 Fully implantable Evoke System 20 6 1 Percutaneous lead and stimulator implant procedure 20 6 2 Programming 20 6 3 How it should feel 20 6 4 The CLS 21 7 The Evoke Pocket Console EPC 22 7 1 EPC buttons and indicators 23 7 2 EPC audio indicators 25 7 3 Changing the battery in your EPC 26 8 The Evoke C...

Page 3: ...ooting 35 14 Package contents 38 15 Technical Specifications 38 15 1 Device Specifications 38 15 2 Wireless Communication 45 15 3 Electromagnetic Interference 46 16 Glossary 50 17 Symbols 51 18 Contact us 53 Trademarks Saluda Evoke and the Saluda Medical logo are registered trademarks of Saluda Medical Pty Ltd Copyright 2022 Saluda Medical Pty Ltd Sydney Australia All rights reserved Manuals are a...

Page 4: ...s leads and is implanted under the skin for long term therapy The CLS delivers automatic or manually controlled therapy through your percutaneous leads Evoke 12C Percutaneous Leads The Evoke 12C Percutaneous Leads are placed in the epidural space overlying your spinal cord and are connected to the eCLS for a trial period or permanently implanted and connected to the CLS for long term therapy You m...

Page 5: ...didates 4 Safety information Although FDA has determined that the probable benefits outweigh the probable risks there remains some uncertainty on the long term systemic toxicity risks of the leads lead extensions and anchors of the device As a condition of approval FDA is requiring the manufacturer to provide additional long term systemic toxicity information 4 1 Warnings Diathermy You should not ...

Page 6: ...rs may be affected by your Evoke System You should not use your Evoke System if you have any implanted cardiac devices due to interference between them The effect of other implanted stimulators on your Evoke System is unknown We recommend that you should consult your doctor before undergoing implantation of other medical devices Strong electromagnetic fields may cause you discomfort Avoid strong e...

Page 7: ...o prevent risk of skin irritation redness or injury If you experience pain or discomfort during charging you should stop and contact your clinician Before any other surgical procedures notify your clinician or dentist that you have an implanted stimulator Some surgical procedures use electrical current that could affect your implanted stimulator and leads cause serious injury to you and or may dam...

Page 8: ...igh frequency sound waves to create images of your internal organs or to monitor the state of a pregnancy High intensity ultrasound which uses very high frequency sound waves to create heat inside bones or muscle Transcutaneous electrical nerve stimulation TENS which uses electric current to stimulate nerves for therapeutic purposes Psychotherapeutic procedures such as Transcranial Magnetic Stimul...

Page 9: ...r head repetitively You may experience temporary pain at the implant site as the incisions heal after the surgery If you notice redness or feel irritation at the wound site contact your clinician to check for infection Do not try to move your stimulator by pushing it under your skin It is normal to be able to feel the stimulator under your skin do not try to move it or relocate it by pushing or ma...

Page 10: ...s of time Do not store your devices in humid environments such as the bathroom Avoid storing the eCLS at temperatures below 14 F 10 C or above 131 F 55 C Avoid 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 room temp...

Page 11: ...ries in the correct orientation by observing the plus and minus marks on the batteries and the EPC Do not mix batteries that differ by manufacturer brand type age or previous usage Replace both batteries at the same time Do not touch the battery contacts in the EPC Do not short circuit batteries e g do not let terminals of batteries contact each other do not place batteries loose in pockets etc Do...

Page 12: ... or unforeseeable Despite all reasonable precautions you might develop medical complications from having a SCS system Potential risks of implantation and use of a SCS system Undesirable changes in stimulation sensation and or location Uncomfortable changes in stimulation over and or under stimulation Temporary or persistent post surgical pain at hardware implantation sites CLS migration or sub opt...

Page 13: ...ds or lead extensions will be connected to an External Closed Loop Stimulator eCLS to deliver stimulation pulses through your leads to your spine o Your eCLS will be supplied fully charged If the eCLS battery becomes depleted please return to your clinic for battery recharge or replacement You will control the eCLS with the Evoke Pocket Console EPC 5 1 Percutaneous lead placement procedure The lea...

Page 14: ...h 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 so they can reprogram your device to restore comfortable therapy for your pain relief At the end of your trial stimulation period your clinician will ask about the amount of pain relief you experienced...

Page 15: ...and the leads will remain implanted in the same place 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 and 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 Syst...

Page 16: ... when it is time to recharge the eCLS see Section 8 5 5 3 Stopping stimulation There are two ways to stop therapy 5 5 3 1 Using the EPC 1 Unlock the EPC by pressing 2 Press to stop the therapy or 5 5 3 2 Using a magnet 1 Hold the provided magnet over the eCLS for 2 3 seconds until you feel stimulation stop Note If you have misplaced the supplied magnet please contact your clinician 5 5 4 Do not op...

Page 17: ...m the case 4 Remove the lead adapters from the eCLS see Figure 5 2 noting the port that each lead adapter was removed from 5 Secure the lead adapters to your back using adhesive tape to ensure 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 t...

Page 18: ...linic If your clinician instructs you to have a care giver reconnect the components they should 1 Rest the lead adapter on the guide on the side of the eCLS and gently push the lead adapter plug into the socket on the eCLS port until it clips into place see Figure 5 2 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 connect...

Page 19: ...g care to keep the leads in the slots in the seal close the eCLS case by folding the case shut until it snaps closed see Figure 5 4 Caution The leads may be damaged when the case is closed if they are not in the slots in the seal at the lead exits This could disrupt your trial stimulation 8 Secure the eCLS comfortably to your back using adhesive tape or the Evoke Accessory Belt See Section 9 The E...

Page 20: ...e top of the buttocks the flank abdomen or other site as chosen by you and your doctor Note You should tell your doctor on which side you would like the CLS to be implanted 5 The incisions at the lead insertion site and at the stimulator site will be closed and covered with a dressing 6 2 Programming After surgery the CLS will be configured to deliver therapy according to your needs Your clinician...

Page 21: ... needs to be recharged regularly in order to continue delivering therapy Refer to Section 8 for instructions on how to charge the CLS using the Charger 6 4 2 1 Battery Best Practices You may prolong the life of your CLS battery by Recharging it periodically even if it is not fully discharged Recharging it before it completely drains 6 4 3 Stopping stimulation from the CLS There are two ways to sto...

Page 22: ...ger than 10 seconds or the CLS will shut down When the CLS is shut down the EPC will not control the CLS To restart the CLS you must start charging see Section 8 Once charging has started you will be able to control the CLS with the EPC again see Section 7 7 The Evoke Pocket Console EPC Figure 7 1 The EPC to control your stimulator CLS or eCLS The EPC is for controlling your therapy During the tem...

Page 23: ...ally after 2 minutes this does not cause the stimulator to turn off Stop button Press the Stop button to stop therapy immediately After turning stimulation off you can start therapy again by pressing Caution You must unlock the EPC before you can use the Stop button Increase Therapy and Decrease Therapy buttons You can increase your therapy from off to a comfortable level using the Increase Therap...

Page 24: ...stored in your stimulator One of the Selected Program indicators will glow to show the program you have selected 1 Press the Change Program button once and the Selected Program indicator will start flashing 2 Press the Change Program button again until the desired program is selected 3 After 2 seconds the Selected Program indicator will stop flashing stimulation will turn off and the stimulator wi...

Page 25: ...cian 7 2 EPC audio indicators In addition to the visual indicators on the front of the EPC the EPC will beep to indicate various functions A short beep will occur every time you press a button A long beep means your EPC has successfully communicated its command to the Evoke CLS or eCLS and a change has been made Two beeps indicates that the Evoke CLS or Evoke eCLS has reached a limit and did not a...

Page 26: ...on when the stimulator has reached a limit 2 beeps or when the stimulator did not receive the request 3 beeps For more information refer to Section 7 2 Follow the steps below to turn audio indicators back on 1 Turn the EPC off 2 Press and hold the button until you complete the next step 3 Press and hold the button until the EPC turns on 7 3 Changing the battery in your EPC Two AAA alkaline batteri...

Page 27: ... 8 1 The Charger and Charger coil The Evoke Charger is used to charge the battery in your implanted CLS The Charger coil is used to wirelessly transfer charge to the CLS battery 8 1 Charger buttons and Indicators Start Charging button Press the Start Charging button for more than 1 second after placing the coil over the implant to commence the charging cycle CLIN UMAN 005176 Revision 4 01 Page 27 ...

Page 28: ...e To improve the quality of the link between the Charger coil and the Evoke CLS move the coil closer to the implant Charger Battery Level indicator The Charger Battery Level indicator shows the battery level in the Charger Caution As the Charger provides the charge for recharging the CLS battery it is important to start the charging session with a full Charger battery If the charge falls to one ba...

Page 29: ... CLS battery the CLS will stop delivering therapy Contact Clinician indicator The Contact Clinician indicator will flash six times if the Charger detects a problem with itself or the CLS and requires your clinician s attention to resolve If the Contact Clinician indicator flashes you need to contact your clinician so that they can investigate further Note The Contact Clinician indicator will not c...

Page 30: ...l into the Accessory Belt pouch to hold the coil in place see Section 9 2 4 Place Charger coil over clothing or fabric to ensure no prolonged contact with your skin 5 Press for more than one second 6 The Charger will beep every second until the coil starts to align with the CLS The Charging Link indicator will then show at least two bars 7 Move the Charger coil until the link is strongest The Char...

Page 31: ...r illuminates 8 3 Charger audio indicators In addition to its visual indicators the Charger will beep to indicate various functions A short beep will occur every time you press a button A long one second beep accompanied by all the bars glowing on the CLS Battery Level indicator for 10 seconds indicates that the charge session is complete A long one second beep where the battery level indicator do...

Page 32: ...uring the trial stimulation period you may wear an Accessory Belt to hold the eCLS Place the eCLS into the Accessory belt using the following steps 1 Place eCLS into the Accessory Belt pouch with the leads exiting the pouch at the top Figure 9 1 2 Close the pouch by pressing the Velcro sides together The Velcro will fasten around the leads exiting the pouch 3 Wrap the elasticated portion of the be...

Page 33: ...ill fasten around the cable or leads exiting the pouch 3 Wrap the elasticated portion of the belt around your waist and attach its Velcro end to either the pouch or the belt itself The belt should fit comfortably and securely around your waist 4 Follow the Charger instructions see Section 8 2 to charge the CLS 5 Adjust the belt position if you need to re align the Charge coil to the CLS 6 When fin...

Page 34: ...ur stimulation system 11 Disposal of devices Caution Your eCLS EPC and Charger contain batteries that could explode if they are placed into a fire These items must not be discarded in the normal municipal waste please return to Saluda Medical for disposal via your clinical team 12 Patient ID Card Every CLS is supplied with a Patient ID card for the clinician to complete and give to you Keep this c...

Page 35: ...ep once per second when there is a poor link my Charger beeps between the Charger and the CLS continuously Reposition the Charger coil over the implant so that the Charging Link indicator shows at least 2 bars Note Wait about 1 second between each reposition in order for the Charger to update the link My Charger The link between the Charger coil and your CLS has dropped started beeping below two b...

Page 36: ...ow a Please contact your clinical team to organize battery recharge or replacement 2 Lead Disconnection a Do not open the eCLS Case b Please contact your clinical team If you have a fully implanted CLS 1 Stimulator Battery too Low a Place the Charger coil over the CLS and press the Start Charging button for 2 seconds b If the CLS battery was low allow it to recharge refer to Section 8 The Evoke Ch...

Page 37: ...the stimulator and try again If you have a CLS bring the EPC to the side where the CLS is implanted or try to hold it directly behind the implant site If the stimulation is off 1 See My therapy has stopped I cannot change To change programs you will have to press the button programs once do not hold it and then press it again while it is still flashing until you select your desired program Refer t...

Page 38: ...voke 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 cm 2 in Weight 50 g 1 76 oz Lead ports 2 Each lead or lead extension is secured by a set screw at the port entry Electrodes 25 Port 1 electrodes 1 12 Port 2 electrodes 13 24 CLS ...

Page 39: ...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 24 hours of therapy At higher or lower settings this defined end of life could be shorter or longer respectively Charging Transcutaneous charging using inductive coupling with an external coil Implant depth 5 mm to 20 mm 0 2 in to 0 8 in Recording Low 250x amplifi...

Page 40: ...ted when the communication session begins Battery 800 mAh 3 6 V Li ion rechargeable battery Charging Li Ion battery charger Ingress Protection IP22 Rating for protection against access of solid objects greater than eCLS in case or equal to 12 5 mm and for vertically dripping water when the device is tilted 15 degrees eCLS IP30 Rating for protection against solid objects greater than or equal to 2 ...

Page 41: ...ellethane Distal electrodes Platinum Iridium Proximal connectors Platinum Iridium Retention ring Conductors 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 12 Length Pitch 3 mm 0 12 in 7 mm 0 276 in Connectors Length Pitch 1 02 mm 0 040 in 1 96 mm 0 077 in center to center Storage Transportation Conditions Temp...

Page 42: ...nium Header body 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 12 Length Pitch 1 02 mm 0 040 in 1 96 mm 0 077 in center to center Storage Transportation Conditions Temperature Min 10 C 14 F Max 55 C 131 F 1 Alloy of Nickel Cobalt Chromium and Molybdenum MP35N is not in contact with tissue but may...

Page 43: ...on session begins Power Source 2 x AAA Alkaline batteries Battery Life Approx 60 days dependent on usage Expected Service 1 year Life Ingress Protection IP22 Rating for protection against access of solid objects greater than or equal to 12 5 mm and for vertically dripping water when the device is tilted 15 degrees IEC 60601 1 Type BF Applied Part EN 60601 1 Internally Powered Medical Electrical Eq...

Page 44: ...ertically dripping water when the device is tilted 15 degrees IEC 60601 1 Type BF Applied Part EN 60601 1 Internally Powered Medical Electrical Equipment Classification Continuous Operation Storage Temperature Min 20 C 4 F Max 60 C 140 F Transportation Humidity Min 0 RH Max 90 RH Conditions Pressure 70kPa 0 69 atm Max 150kPa 1 48 atm Temperature Min 5 C 41 F Max 30 C 86 F Operating Conditions Humi...

Page 45: ...e frequency band and selects the least congested channel for communication All communication is error checked and is retried automatically The user is notified if the wireless communication link fails to connect The communication range between the EPC and the CLS eCLS is typically 1 m 3 3 feet If you experience issues with the wireless communication between the EPC and CLS eCLS try the following H...

Page 46: ...that it is used in such an environment Emissions Test Compliance Electromagnetic environment guidance Radiated disturbance 30 MHz 6000 MHz CISPR 11 EN 55011 Group 1 The Evoke SCS System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment Conducted Emissions 0 15 MHz 30 MHz CISPR 11 EN 5501...

Page 47: ...frequency for power supply lines to Charger power adapter Mains power quality should be that of a typical household commercial or hospital environment If the user of the Charger power adapter requires continued operation during mains power interruptions it is recommended that the Charger power adapter be powered from an uninterruptible power supply or a battery Surge Immunity IEC 61000 4 5 0 5 kV ...

Page 48: ...o closer to any part of the Evoke SCS System including cables than the recommended separation distance stated below Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic environment guidance Conducted RF IEC 61000 4 6 3 Vrms 150 kHz to 80 MHz 6 Vrms in ISM and amateur radio bands between 150 kHz and 80 MHz 80 AM at 1 kHz The Charger power adaptor functioned correctly during the test ...

Page 49: ...ity fields from RF wireless Up to 28 V m at 0 3m at specified Tested at up to 28 communications frequencies V m devices continued equipment refer Table 9 IEC 60601 1 2 to function during test CLIN UMAN 005176 Revision 4 01 Page 49 of 53 ...

Page 50: ...e responses from spinal cord nerves Evoke Pocket Console EPC A remote controller that allows the patient to adjust the therapy output from the CLS eCLS Evoked Compound Action The electrical signal from multiple nerve fibers in Potential ECAP response to an electrical stimulus pulse External Closed Loop Simulator The eCLS is a non implantable device with the same eCLS functionalities as the CLS Lea...

Page 51: ... Lot number YYYY MM DD Use by date YYYY year MM month DD day Caution Temperature limitation F and C Manufacturer YYYY MM DD Date of manufacture YYYY year MM month DD day Do not dispose of this product in the unsorted municipal waste stream dispose of this product according to local regulations Type BF applied part Non ionizing electromagnetic radiation Do not use if package is damaged MR Unsafe No...

Page 52: ...ping water when the device is tilted 15 degrees IP30 Ingress Protection Rating 30 Protected against solid objects greater than or equal to 2 5mm and no protection against water Class II Medical Electrical Equipment Power supply connection Serial Connection Caution Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner CLIN UMAN 005176 Revision 4 01 Page ...

Page 53: ...l com and or www saludamedical com manuals If you have any further questions please email us at info saludamedical com Legal Manufacturer US Office Saluda Medical Pty Ltd Saluda Medical Americas Inc 407 Pacific Highway 9401 James Ave S Artarmon NSW 2064 Suite 132 Australia Bloomington MN 55431 USA T 61 2 8405 8700 T 1 952 491 4256 CLIN UMAN 005176 Revision 4 01 Page 53 of 53 ...

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