Medtronic Itrel 4 Reference Manual
Itrel® 4
NEUROSTIMULATOR FOR
SPINAL CORD STIMULATION
PROGRAMMING
REFERENCE
GUIDE
Overview
This guide describes many primary attributes of the
Itrel® 4 neurostimulation system and the model 8840 N’Vision®
programmer. This guide does not replace the product
technical manuals. For complete instructions, indications,
contraindications, warnings, and precautions, consult the
product technical manuals referenced on page 48.
The following products are referenced:
Itrel® 4 neurostimulator (models 37703 and 37704)
MyStim® patient programmer (model 37746)
External Neurostimulation System (ENS) (model 37022)
N’Vision clinician programmer (model 8840)
Overview
3
Table of Contents
PROFILE 13
START SESSION 19
MEASUREMENT 21
CONTENTS
4
Contents
General Programming Sequence . . . . . . . . . . . . . . . . 7
Program Button . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
Pain Test Stim . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Program and Parameter Settings . . . . . . . . . . . . . . . 11
Program. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Parameter Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Prole
Patient Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Lead Conguration . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Device Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Start Session
Start Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Measurement
Electrode Impedance . . . . . . . . . . . . . . . . . . . . . . . . 20
Therapy Measurements . . . . . . . . . . . . . . . . . . . . . . . 22
Battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Program MyStim
Program MyStim . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Limits/Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
MyStim Programmer . . . . . . . . . . . . . . . . . . . . . . . . . 30
Initial Settings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
End Session
Print Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Print Screen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
End Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Slider Bar . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
Session Data Manager . . . . . . . . . . . . . . . . . . . . . . . 42
MyStim Programmer Troubleshooting . . . . . . . . . . . 44
Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
References . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Disclosure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Table of Contents
5
General Programming Sequence
6
General Programming Sequence
Turn the N’Vision programmer ON.
a
Select the Neurostimulator icon to navigate to the
b
Neurostimulation Desktop screen.
Hold the programming head steady over the
c
neurostimulator and press the PROGRAMMING key.
Access the PROFILE menu. Enter/review patient
d
information, lead conguration, neurostimulator and
implant information, and set/review neurostimulator
date and time.
Access the START SESSION menu. Review patient
e
use information and check the Observations box for
signicant system events that may have occurred.
Access the MEASUREMENT menu. Run diagnostic tests
f
and review battery information.
Access the PROGRAM MyStim menu. Program the
g
device.
Access the END SESSION menu. Verify that all settings
h
are correct and end the session.
General Programming Sequence
Program Button
Once you have entered new parameters or settings into the
programmer, press the Programming
Program button
your changes to the implanted device. If you have pending
parameters , you will be unable to change screens until
you have programmed the new parameters.
on the screen to send or program
P
key or select the
7
Pain Test Stim
To program for intraoperative screening or postoperative test
stimulation, the model 37022 External Neurostimulator (ENS) is
connected to the model 8840 Clinician Programmer. The model
8870 application card provides the software to program the ENS
for these procedures.
Screening and test stimulation options are available after initial
interrogation and ENS identication.
Note: When using the ENS for intraoperative screening or
postoperative test stimulation, the N’Vision programmer
software takes approximately 60 seconds to load.
Intraoperative
a
Select for intraoperative screening with minimal
programming capabilities (e.g., electrode and impedance
measurements).
• Previous session information not retained
•May be used to identify optimal lead position
New
b
Select for new test stimulation with full programming
capabilities.
•Previous session information not retained
•May be used to set up and conduct a trial
Pain Test Stim
Follow-up
c
Select for test stimulation follow-up with full
programming capabilities.
•Previous session information retained
•May be used for reprogramming during a trial or
at the completion of a trial
8
a
b
c
Pain Test Stim
9
Program and Parameter Settings
10
Program and Parameter Settings
Program
The primary goal of programming is to superimpose the
stimulation or paresthesia pattern over the patient’s pain
pattern and to establish the correct stimulation parameter
values.
A program is a specic combination of pulse width, rate, and
amplitude settings acting on a specic electrode combination.
Parameter Settings
Amplitude* ( ) : 0-10.0 V with 0.05-V or 0.1-V resolution
10.0-10.5 V with 0.1-V resolution
Program and Parameter Settings
Pulse Width* (
Rate* (
10-130 Hz with 5 Hz resolution
): 60-450 µs (10-µs resolution)
): 2-10 Hz with 1 Hz resolution
11
Patient Data
Use for rst-time setup of patient information displayed
across other screens. Information is stored in the implantable
neurostimulator (INS) and/or external neurostimulator (ENS)
Patient Data
for future use.
Access the Prole menu and select Patient Data
a
Patient ID
b
Select to enter patient name, ID number, or any other
appropriate information.
Patient Diagnosis
c
Touch to select patient diagnosis from the dropdown list or select the eld to enter another diagnosis.
Physician Information
d
Select to enter physician name, phone number, or any
other appropriate information.
Notes
e
Touch to open Notes screen and enter any desired
information.
Patient Session Name
f
Displays neurostimulator serial number. Also displays
patient name if entered on the Patient Data screen.
12
PROFILE
a
b
Patient Data
c
d
e
f
13
Lead Conguration
Use for rst-time setup of device conguration information
displayed across other screens. Information is stored in
the implantable neurostimulator (INS) and/or external
neurostimulator (ENS) for future use. (Note: The screen shown
on page 15 is for the Itrel 4 INS. The screen looks dierent for
the ENS.)
Access the Prole menu and select
a
Lead Conguration
Lead Conguration
b
Touch to select the appropriate lead conguration
from the drop-down list.
Flip Leads Vertically button
c
Lead Conguration
If appropriate, select to ip the lead orientation.
14
a
b
c
Lead Conguration
15
Device Data
Information is stored in the implantable neurostimulator (INS)
and/or external neurostimulator (ENS) for future use.
Access the Prole menu and select Device Data
a
Date and Time
b
View the current system date and time stored in the
neurostimulator. To reset the date and time, select the
input box and use the Increase and Decrease buttons or
select the Match N’Vision button on the Date and Time
screen.
Location
c
Touch to select the neurostimulator implant location
from the Location drop-down list or to enter another
location.
Implantation Date
d
Select to enter the date the neurostimulator was
implanted.
About Device
e
Select to view information about the N’Vision
programmer, INS, and MyStim programmer.
Device Data
16
Loading...