Document Reference: ENG-UMAN-000730
Revision: 6.00
Page 5 of 40
Name:
Clinical System Transceiver (CST)
Ref No.:
0004
The Clinical System Transceiver (CST) is a plug in device that enables exchange of
information wirelessly between the CI and the stimulator.
Name:
Evoke™ Tunneling Tool Kit
Ref No.:
0012
The Evoke™ Tunneling Tool allows the subcutaneous threading of leads and/or extensions
either to an exit incision for the trial stimulation period or to the CLS.
Name:
Evoke™ Spares Kit
Ref No.:
0015
The Evoke™ Spares Kit contains all items from the permanent lead kits except for 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 4.5” needle supplied with the lead kits is too short to reach the epidural space.
2
Intended 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
The Evoke™ System should not be used in patients who:
•
Do not receive effective pain relief during trial stimulation
•
Are unable to operate the system
•
Are unsuitable surgical candidates
