Indications For Use - What The Evoke System Is Used For; Contraindications - When The Evoke System Must Not Be Used; Safety Information; Warnings - SALUDA MEDICAL Evoke SCS User Manual

• Evoke Accessory Belt. The Evoke accessory belt is an elasticated belt with a pouch that
you wear to hold either the eCLS or Charger coil in place.
2 Indications for use – What the Evoke System is used for
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.
3 Contraindications – When the Evoke System must not be used
The Evoke SCS System should not be used in patients who:
• Do not receive effective pain relief during trial stimulation.
• Are unable to operate the Evoke SCS System.
• Are unsuitable surgical candidates.

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 be subjected to shortwave, microwave and/or therapeutic ultrasound
diathermy.
• Diathermy generates energy that may cause heating at the lead site, resulting in tissue
damage, severe injury, or death.
• It may also cause damage to the CLS and you may need surgery to replace it.
Magnetic Resonance Imaging (MRI) scans
The Evoke System is considered MR Unsafe, as the safety of this system within an MRI
environment has not been tested.
• Under no circumstances should you have an MRI scan while you have the Evoke System.
CLIN-UMAN-005176
Evoke® SCS System User Manual
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