Document Reference: ENG-UMAN-000731
Revision: 5.00
Page 5 of 61
Name: Evoke Charger
Catalogue Number: 0006, 2006
The Evoke Charger allows you to recharge the battery in a CLS. The Charging coil
(attached to the Charger) is placed over the CLS and the charge is transferred
through the skin from the Charger to the CLS.
The Charger kit also includes a power adapter for recharging the Charger.
Name: Evoke Clinical Interface (CI)
Catalogue Number: 0024, 2024
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.
Name: Clinical System Transceiver (CST)
Catalogue Number: 0004, 2004
The Clinical System Transceiver (CST) is a plug in device (USB connection) that
enables exchange of information wirelessly between the CI and the stimulator.
2
Indications for Use
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
Patient must be advised of the following contraindications:
The Evoke system must not be used in children under 18 years-old.
The Evoke system must not be used in patients who are pregnant.
4
Safety Information
Patients must be advised of the following warnings and precautions.
4.1
Warnings
Diathermy
Patients implanted with the Evoke System should not be subjected to shortwave,
microwave and/or therapeutic ultrasound diathermy.
Diathermy generates energy that may cause heating at the percutaneous lead site
resulting in damage to the CLS, tissue damage, severe injury or death.
Magnetic Resonance Imaging (MRI)
As the Evoke System has not been tested for MRI compatibility, it is considered MRI
unsafe.
