SALUDA MEDICAL Evoke, Clinical Manual

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Document Reference: ENG-UMAN-000731 Revision: 5.00 Page 2 of 61
Table of Contents
PRIVACY STATEMENT ...................................................................................................... 3
1
DESCRIPTION ........................................................................................................... 4
2 INDICATIONS FOR USE ............................................................................................. 5
3 CONTRAINDICATIONS .............................................................................................. 5
4 SAFETY INFORMATION ............................................................................................. 5
4.1 W
ARNINGS
....................................................................................................................5
4.2 P
RECAUTIONS
.................................................................................................................7
4.3 P
OTENTIAL
R
ISKS
..........................................................................................................11
5 INTRA-OPERATIVE PROGRAMMING WITH THE CI ................................................... 12
5.1 C
ONFIRMATION OF
O
PTIMAL
L
EAD
P
LACEMENT
..................................................................12
5.2 C
ONFIRMATION OF
P
ROPER
CLS C
ONNECTION
...................................................................14
6 POST-OPERATIVE PROCEDURES .............................................................................. 14
6.1 C
ONNECTING AN E
CLS
TO
E
XTERNALIZED
L
EADS
.................................................................14
7 CLINICAL PROGRAMMING - INTRODUCTION ........................................................... 18
7.1 C
LINICAL
I
NTERFACE
(CI) ................................................................................................18
7.2 C
LINICAL
S
YSTEM
T
RANSCEIVER
(CST) ..............................................................................19
8 CLINICAL PROGRAMMING – USING THE CPA .......................................................... 19
8.1 P
ROGRAMMING OVERVIEW
.............................................................................................19
8.2 C
ONNECTING THE
CI
TO THE
CST
AND E
CLS/CLS ...............................................................20
8.3 S
ET STIMULATOR TIME
...................................................................................................22
8.4 R
ETRIEVE OR SET THE
P
ATIENT
ID
AND
P
ATIENT
Z
ONE
..........................................................23
8.5 M
EASURE ELECTRODE IMPEDANCE
....................................................................................24
8.6 S
ET UP LEAD ORIENTATION
..............................................................................................25
8.7 C
HOOSE THE STIMULATION ELECTRODES AUTOMATICALLY
......................................................26
8.8 S
TART AND STOP STIMULATION
........................................................................................27
8.9 S
ET UP
ECAP
MEASUREMENT
..........................................................................................28
8.10 S
ET UP
F
EEDBACK
C
ONTROL
(FC)
THERAPY
.....................................................................30
8.11 E
NABLE
F
EEDBACK
C
ONTROL
.......................................................................................31
8.12 S
AVE A
P
ROGRAM TO THE STIMULATOR
.........................................................................31
8.13 I
NTERLEAVED
S
TIMULATION
.........................................................................................33
8.14 N
EUROPHYSIOLOGICAL
M
EASUREMENTS
........................................................................36
9 CLINICAL INTERFACE – SETTINGS GUIDE ................................................................. 42
9.1 S
TIMULATION
S
ETTINGS
M
ENU
........................................................................................42
9.2 M
EASUREMENT AND
F
EEDBACK
S
ETTINGS
M
ENU
................................................................42
9.3 E
LECTRODE SELECTION MODES
.........................................................................................43
9.4 C
URRENT
S
TEERING
.......................................................................................................43
9.5 P
ATIENT
P
ERCEPTION
.....................................................................................................44
9.6 CLS M
ENU
..................................................................................................................45
9.7 N
AVIGATION
M
ENU
......................................................................................................46
9.8 S
ETTINGS
M
ENU
...........................................................................................................47
9.9 E
RROR
D
ISPLAY
............................................................................................................48
10 OPERATION OF STIMULATOR WHEN ERRORS OCCUR ............................................. 49
10.1 O
UT OF
C
OMPLIANCE
.................................................................................................49
10.2 R
EFERENCE
C
LOCK
E
RROR
...........................................................................................49
10.3 E
LECTRODE
D
ISCONNECTED
.........................................................................................50
10.4 C
URRENT AT
M
AXIMUM
.............................................................................................50
10.5 ERT C
LIPPING
...........................................................................................................50