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SALUDA MEDICAL Evoke 12C, Хирургическое руководство

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Document Reference: ENG-UMAN-000730 

Revision: 6.00 

Page 2 of 40 

Table of Contents 

1

 

DESCRIPTION ............................................................................................................ 4

 

2

 

INTENDED USE .......................................................................................................... 5

 

3

 

CONTRAINDICATIONS ............................................................................................... 5

 

4

 

SAFETY INFORMATION .............................................................................................. 6

 

 

W

ARNINGS

 ..................................................................................................................... 6

 

 

P

RECAUTIONS

 .................................................................................................................. 8

 

 

P

OTENTIAL 

R

ISKS

 ............................................................................................................ 10

 

5

 

PERCUTANEOUS LEAD IMPLANT PROCEDURE .......................................................... 12

 

 

O

VERVIEW

 .................................................................................................................... 12

 

 

P

ERCUTANEOUS 

L

EAD 

P

LACEMENT

 .................................................................................... 12

 

6

 

ANCHOR THE LEAD .................................................................................................. 15

 

 

P

OSITION THE ANCHOR

 .................................................................................................... 15

 

 

S

ECURE THE ANCHOR

 ....................................................................................................... 15

 

 

C

REATE A STRAIN RELIEF LOOP IN THE LEAD

 .......................................................................... 17

 

7

 

LEAD TUNNELING AND CLS IMPLANT PROCEDURE ................................................... 17

 

 

L

OCATE AND CREATE A POCKET FOR THE 

CLS ........................................................................ 17

 

 

T

UNNEL THE LEAD PROXIMAL CONNECTORS AND CONNECT TO THE 

CLS ..................................... 17

 

 

A

NCHOR THE 

CLS,

 CLOSE AND DRESS THE INCISIONS

 .............................................................. 21

 

 

P

OST

-O

PERATIVE 

P

ROCEDURES

 ......................................................................................... 21

 

8

 

TRIAL WITH A TEMPORARY PERCUTANEOUS LEAD .................................................. 22

 

 

R

EMOVE THE STYLET AND EPIDURAL NEEDLE

 ......................................................................... 22

 

 

A

NCHOR THE LEAD

,

 CLOSE AND DRESS THE INCISIONS

 ............................................................. 22

 

 

P

OST

-O

PERATIVE 

P

ROCEDURES

 ......................................................................................... 22

 

 

R

EMOVING A 

P

ERCUTANEOUS 

L

EAD AT THE 

E

ND OF A 

T

RIAL

 ................................................... 22

 

9

 

REVISION, REPLACEMENT AND EXPLANT SURGERY .................................................. 22

 

 

O

PEN THE COMPONENT SITES

 ............................................................................................ 23

 

 

P

ERCUTANEOUS LEADS

 .................................................................................................... 23

 

 

CLS ............................................................................................................................. 23

 

10

 

INTRA-OPERATIVE TESTING ..................................................................................... 24

 

Содержание Evoke 12C

Страница 1: ...000730 Revision 6 00 Page 1 of 40 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...

Страница 2: ...LEAD 17 7 LEAD TUNNELING AND CLS IMPLANT PROCEDURE 17 LOCATE AND CREATE A POCKET FOR THE CLS 17 TUNNEL THE LEAD PROXIMAL CONNECTORS AND CONNECT TO THE CLS 17 ANCHOR THE CLS CLOSE AND DRESS THE INCISIO...

Страница 3: ...CE OF THE EVOKE ECLS 30 14 PACKAGE CONTENTS 31 15 SPECIFICATION 33 EVOKE CLS 33 EVOKE ECLS 34 EVOKE 12C PERCUTANEOUS LEAD INCLUDES TRIAL LEADS 35 SURGICAL ACCESSORIES 35 EVOKE CI SPECIFICATIONS 37 EVO...

Страница 4: ...he neural response to stimulation Name Evoke External Closed Loop Stimulator eCLS Ref No 0020 During the trial stimulation period the leads are connected to the Evoke External Closed Loop Stimulator e...

Страница 5: ...r the lead itself plus a CLS port plug and torque wrench Name Epidural Needle 6 5 Kit Ref No 0014 The 6 5 Epidural Needle Kit is an optional extra long needle for larger patients in whom the regular 4...

Страница 6: ...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 sti...

Страница 7: ...kin 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 their clinicia...

Страница 8: ...o High output ultrasound o TENS o Psychotherapeutic procedures e g electroconvulsive therapy transcranial magnetic stimulation o Laser procedures If the patient is required to undergo any of these th...

Страница 9: ...ng 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 dam...

Страница 10: ...g 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...

Страница 11: ...he 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 intr...

Страница 12: ...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...

Страница 13: ...ve during needle and lead placement to help mitigate any risk of neural injury 2 Using an Epidural Needle from the surgical tools insert the needle with the bevel up and a paramedian approach refer to...

Страница 14: ...he bent stylet with the straight stylet if required Confirm optimal placement of the lead Physicians may have a preference on the method to confirm optimal lead placement in the operating room Lead po...

Страница 15: ...he 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 M...

Страница 16: ...wrench B Active anchor with screw secured against lead 2 Use the torque wrench to gently tighten the setscrew clockwise until you hear a click and tie 1 2 or 3 sutures as needed to secure anchor to fa...

Страница 17: ...he anchor 7 Lead Tunneling and CLS Implant Procedure Locate and create a pocket for the CLS Typically the pocket is located in soft fleshy tissue at the top of the buttocks or on the patient s flank 1...

Страница 18: ...d incision site and the CLS pocket 3 Insert the tunneling tool subcutaneously from the lead incision site to the intermediate incision site 4 Withdraw the tunneling tool leaving the straw in the tunne...

Страница 19: ...LS partially within the CLS pocket 5 Confirm correct connection Note This step is to be completed by the programming clinician outside of the sterile field The Evoke Clinical Manual provides specific...

Страница 20: ...Create a strain relief loop at the CLS port entry Figure 7 5 Note The strain relief loop takes up any excess length and reduces tension in the lead at the lead exit from the CLS port during movement E...

Страница 21: ...writing on the CLS is facing up towards the skin so that charging will be possible 3 Ensure that the CLS is between 0 5 cm to 2 0 cm 0 2 in and 0 8 in under the skin so that charging will be possible...

Страница 22: ...ng directly to the percutaneous lead may damage the lead or cause it to fail Post Operative Procedures For post operative procedures and programming refer to the Evoke Clinical Manual Removing a Percu...

Страница 23: ...nsert a stylet into the lead b Guide the lead to the required position refer to sections 5 2 3 to 5 2 4 Note If intra operative testing via paresthesia generation is to be performed go to section 10 I...

Страница 24: ...dapter slot The stylet fits into the groove on the lead adapter Note it is not necessary to remove the lead Stylet Figure 10 2 Placing tip of proximal connector into lead adapter slot with stylet fitt...

Страница 25: ...ver 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 clip...

Страница 26: ...ng 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 Figure 10 6 Placing a second lead adapter into the lead...

Страница 27: ...mpedance using the CI to ensure the leads are connected properly o If electrode impedance is greater than 4000 check all the connections o Check impedance after each reconnection of the proximal conne...

Страница 28: ...a new position o If moving the percutaneous lead with stimulation on activate FC to automatically adjust current o Retest paresthesia coverage after changing settings or moving the percutaneous lead...

Страница 29: ...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 2 Hold the top cover between th...

Страница 30: ...nt that does not require sterilization The eCLS should be cleaned regularly as detailed in Section 13 Maintenance of the Evoke eCLS 12 Patient ID Card Every CLS is supplied with a Patient ID Card for...

Страница 31: ...n diameter 2 x Evoke Suture Anchors 1 x Evoke Active Anchor 1 x Torque Wrench 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 1 x Strai...

Страница 32: ...compatible with 60 cm Percutaneous Lead 1 x Torque Wrench 1 x Evoke CLS Port Plug Evoke 12C Trial Lead Kit 60 cm Ref No 0016 Evoke 12C Trial Lead Kit 90 cm Ref No 0017 1 x Evoke 12C Percutaneous Lead...

Страница 33: ...Port 2 electrodes 13 24 CLS case is electrode 25 Stimulation parameters Current 0 mA 50 mA 20mA 750 Pulse Width 20 s 1000 s Frequency 10 Hz 1500 Hz Radio frequency communication MICS band 403 MHz Ran...

Страница 34: ...ket TPE Cable TPE 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 Battery Same as the CLS See Section 15 1 Functional specifications All functional specifications are...

Страница 35: ...276 in Connectors Length 1 mm 0 039 in Pitch 1 96 mm 0 077 in center to center Surgical Accessories Table 15 4 Surgical Accessories Epidural Needle Material Stainless Steel Dimensions Lengths 113mm 4...

Страница 36: ...n Lead Adapter Materials Body ABS Plastic Lustran 348 012002 SnoWhite Plug TPE Dimensions 55 x 13 x 13 mm 2 2 x 0 5 x 0 5 in Lead connection Ports 1 12 spring connectors Au plating on stainless steel...

Страница 37: ...al 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 85mm Width 53mm Depth 16mm Material T...

Страница 38: ...ed to program and analyze the performance of the CLS eCLS Electrode An electrical contact that may be employed to deliver therapeutic current measure neural responses or control closed loop stimulatio...

Страница 39: ...or Use at www saludamedical com manuals Refer to Instruction for Use at www saludamedical com manuals Temperature limitation F and C Manufacturer YYYY MM DD Date of manufacture YYYY year MM month DD d...

Страница 40: ...manual or looking at our website www saludamedical com If you have any further questions please contact your Saluda Medical field clinical engineer FCE Alternatively you can contact us via the detail...

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