SALUDA MEDICAL Evoke 12C, Хирургическое руководство

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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.
The Evoke™ System may be used in conjunction with other pain management therapies, as
determined by the physician.
The Evoke™ System comprises several key components to deliver the therapy.
Table 1.1: Description of Evoke™ System Components
Name:
Evoke™ Closed Loop Stimulator (CLS)
Ref No.: 0002
The Evoke™ Closed Loop Stimulator (CLS) is a totally implanted spinal cord stimulator that
connects to the leads and is implanted under the skin for long-term therapy. The CLS
delivers stimulation through the leads and measures the 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 (eCLS). The eCLS is an external stimulator worn during the trial
stimulation period. The eCLS delivers stimulation through the leads and measures the
neural response to stimulation.
Name: Evoke™ 12C Percutaneous Leads
Ref No.:
0008, 0026 (permanent lead length 60 cm)
0016 (trial lead length 60 cm)
0009, 0027 (permanent lead length 90 cm)
0017 (trial lead length 90 cm)
The Evoke™ 12C Percutaneous Leads are placed in the epidural space overlying the spinal
cord and are connected to an eCLS for a trial stimulation period or to a CLS for long-term
therapy.
One or two leads with 12 electrodes on each lead are implanted.
Name: Evoke™ Lead Adapter Kit
Ref No.: 0028
The Evoke™ Lead Adapter allows connection between the eCLS and the implanted leads.
Name:
Evoke™ Clinical Interface (CI)
Ref No.: 0024
The Evoke™ Clinical Interface (CI) is a tablet computer with a programming application
used by the clinician to adjust the therapy settings in the Evoke™ CLS or Evoke™ eCLS.