Cyberonics 2000TRX User Manual
Physician’s Manual
VNS Therapy® Programming System
For Healthcare Professionals
May 2017
Note: This manual contains
information on the use of the
VNS Therapy programming
software programming
system. Physicians should
refer to the VNS Therapy Pulse
Generator physician’s
manuals for additional
important prescribing and
safety information.
1 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
© Copyright 2017 LivaNova, Inc., Houston, Texas
All rights reserved.
2 of 58 — 26-0009-7500/0 (OUS)
1. DESCRIPTION AND USE 8
1.1. General Description 8
1.1.1. Intended Use 8
1.2. System Communication 8
1.2.1. Programmer Communications 8
1.2.2. Wand Communications 8
1.2.3. Communication Distance 9
1.2.3.1. Wand and Programmer 9
1.2.3.2. Wand and Generator 9
2. PRECAUTIONS 10
3. G
ET STARTED 11
3.1. Parts Included 11
3.2. Prepare System for Use 11
3.3. Basic Operation 11
3.3.1. Charge the Programmer 11
3.3.2. Turn Programmer ON/OFF 12
3.3.3. Turn the Programmer Screen ON/OFF 12
3.3.4. Check Programmer Battery 13
3.3.5. Set the Programmer Date and Time 13
3.3.6. Turn on Wand/Check Wand Battery 13
3.4. Connect Wand/Programmer 15
3.4.1. Preferred Wireless Wand Setup 15
3.4.2. Wired Wand Setup 15
Physician’s Manual — VNS Therapy Programming System
4. INTERROGATING THE GENERATOR 16
4.1. Interrogate (No Preferred Wand) 16
4.2. Interrogate (With Preferred Wand) 18
4.3. Interrogate (Change Preferred Wand) 19
5. HOW TO USE THE SOFTWARE 20
5.1. Summary Screen 20
5.2. Quick Access Bar 21
6. PROGRAM THE DEVICE 23
6.1. Edit Patient Data 23
6.2. How to Adjust Parameter Settings 23
6.3. How to Configure Seizure Detection Settings 25
6.3.1. Turning the Detection Feature ON/OFF 25
6.3.2. Set Heartbeat Detection 26
6.3.3. Use Verify Heartbeat Detection 26
6.3.3.1. Visual Indicators During Verify Heartbeat Detection 27
6.3.4. Set the AutoStim Threshold 27
6.3.5. Stimulation Settings on the AutoStim Tab 28
6.3.5.1. Detection and Time Restraints 28
6.4. Potential Error Conditions Related to Programming 28
6.4.1. Partial Programming (Model 102R) 28
6.4.2. Partial Programming Interruption (Models 103-106 and 1000) 28
6.4.3. Cross-programming (Model 102 Generators ONLY) 29
3 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
7. GUIDED PROGRAMMING 30
8. S
CHEDULED PROGRAMMING 31
9. D
AY/NIGHT PROGRAMMING 32
10.D
EVICE DIAGNOSTICS 33
10.1. Reading Test Results 33
10.2. System Diagnostics 36
10.3. Normal Mode Diagnostics (Model 102) 36
10.4. Magnet Mode Diagnostics 36
10.5. AutoStim Diagnostics (Model 106 and 1000) 37
10.6. Generator Diagnostics 37
10.7. Diagnostic Test Differences Between Models of Generators 37
10.8. Potential Error Conditions Observed in Diagnostics 38
11.HISTORY 39
12.E
VENTS AND TRENDS 40
13.M
14.P
15.T
ANAGING PROGRAMMER INFORMATION 41
ROGRAMMER SETTINGS 42
ROUBLESHOOTING 43
15.1. Non-responsive Programmer or Wand 43
15.2. Communication Issues 43
15.2.1. Wand Not Connecting to Programmer (Wireless) 43
15.2.2. Wand Not Connecting to Programmer (Backup Cable) 44
15.2.3. Wand Not Communicating with Generator 45
15.3. High/Low Lead Impedance and Low Output Current Issues 46
15.3.1. High Lead Impedance in the OR 46
15.3.2. Low Lead Impedance in OR 47
15.3.3. High Lead Impedance at Follow-up Visits (Model 102) 48
15.3.4. High/Low Lead Impedance or Low Output Current at Follow-up Visit (Models 103-106 and 1000)
49
15.4. Generator Battery Issues 50
15.4.1. Low Battery/End of Service Indications in OR 50
15.4.2. New Generator Disabled Due to EOS at First Interrogation 51
15.4.3. Sudden Decrease In Remaining Battery Power 52
15.5. Heartbeat Detection Issues 52
15.5.1. Heartbeat Detection Inaccurate (Over/Under) in OR or at Follow-up Visit 52
15.6. Seizure Detection Issues 53
15.6.1. Inaccurate AutoStims at Follow-up Visit for Generator Model 106 and 1000 53
16.GENERATOR RESET 55
17.MAINTENANCE, HANDLING, AND DISPOSAL 56
17.1. The Programmer 56
17.2. The Wand 56
17.3. Disposal 56
4 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
18.PROGRAMMING SYSTEM SPECIFICATIONS AND GUIDANCE 57
18.1. Wand and Programmer Specification 57
18.2. Electromagnetic Emissions Guidance for Wand 57
19.CONTACT INFORMATION AND SUPPORT 59
List of Tables
Table 1 Diagnostic/Parameter Result Summary 34
Table 2 DC DC Code Conversion and Estimated Impedance Range 36
Table 3 Diagnostic Test Differences Between Models of Generators 37
Table 4 Programming System Specification 57
Table 5 Electromagnetic Emissions 57
Table 6 Electromagnetic Immunity 58
Table 7 Electromagnetic Immunity to Proximity Fields from RF Wireless Communications Equipment 58
List of Figures
Figure 1 System Parts 11
Figure 2 Connect the Charger 12
Figure 3 Power On Programmer 12
Figure 4 Adjust Programmer Time and Date 13
Figure 5 Power On Wand 14
Figure 6 Power Indicator (Battery OK) 14
Figure 7 Low Battery Indicator 14
Figure 8 Wand Battery Replacement 15
Figure 9 Main Screen 16
Figure 10 Wand Search Screen 17
Figure 11 Wand (SN) Selection Screen 17
Figure 12 Successful Wand Connection 18
Figure 13 Interrogate Generator Screen 18
Figure 14 Main Screen - Preferred Wand 19
Figure 15 Summary Screen 21
Figure 16 Quick Access Bar 22
Figure 17 Edit Patient ID Screen 23
Figure 18 Output Warning Screen 24
Figure 19 Confirmation Screen 25
Figure 20 Verify Heartbeat Detection Screen 26
Figure 21 Verify Heartbeat Detection - Test in Progress 27
Figure 22 Programming Failed Warning Screen 29
Figure 23 Accessing Diagnostics 33
Figure 24 Diagnostics Results Example 34
5 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
Figure 25 Solution Steps for a Non-responsive Programmer or Wand 43
Figure 26 Solution Steps For Wand Not Connecting to Programmer (Wireless) 44
Figure 27 Solution Steps for Wand Not Connecting to Programmer (Backup Cable) 45
Figure 28 Solution Steps for Wand Not Communicating with Generator 46
Figure 29 Solution Steps for High Lead Impedance in OR 47
Figure 30 Solution Steps for Low Lead Impedance in OR 48
Figure 31 Solution Steps for High Lead Impedance at Follow-up Visits (Model 102) 49
Figure 32 Solution Steps for High/Low Lead Impedance or Low Output Current at Follow-up Visit (Models 103-
106 and 1000) 50
Figure 33 Solution Steps for Low Battery/End of Service Indications in OR 51
Figure 34 New Generator Disabled Due to EOS at First Interrogation 52
Figure 35 Solution Steps for Heartbeat Detection Inaccurate in OR or at Follow-up Visit 53
Figure 36 Solution Steps for Inaccurate Detection at Follow-up Visit (Model 106) 54
6 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
1. DESCRIPTION AND USE
1.1. General Description
The LivaNova VNS Therapy ® Programmer, Model 3000 version 1.0, and Programming Wand (“Wand”),
Model 2000, allows you to interrogate and program the following VNS Therapy generators:
Model 102 Pulse
Model 102R Pulse Duo
Model 103 Demipulse
Model 104 Demipulse Duo
Model 105 ApsireHC
Model 106 AspireSR
Model 1000 SenTiva
Note: For a list of symbols and terms used with the LivaNova VNS Therapy Programming System, go
to www.VNSTherapy.com/???.
1.1.1. Intended Use
The VNS Therapy Programming System is intended for use only with VNS Therapy generators in a
professional healthcare facility environment, and is subject to the same indications for use.
1.2. System Communication
The VNS Therapy Programming System includes a computer pre-installed with VNS Therapy
programming software and a programming wand. The wand and the programmer connect wirelessly.
The system allows you to:
interrogate and adjust therapy parameters for the generator
assess generator and lead function
view device histories
export session reports
1.2.1. Programmer Communications
The programmer will indicate communication in the following ways:
Musical notes a successful interrogation, diagnostics, or applied changes
Screen messages for successful, failed, or suggested operation
1.2.2. Wand Communications
The wand indicator lights will illuminate when the:
wand is powered on (two green lights below power button)
wand is connected to the programmer (four green lights around the power button)
wand is communicating with the generator (white flashing generator icon)
wand battery is low (orange battery indicator)
7 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
1.2.3. Communication Distance
1.2.3.1. Wand and Programmer
The wireless connection between the programmer and wand will operate up to 3 meters
(approximately 10 feet) under most conditions. If communication is unstable, use the supplied USB
cable to connect the wand and the programmer instead.
1.2.3.2. Wand and Generator
The communication distance between the wand and the generator should not be more than 1 inch.
8 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
2. PRECAUTIONS
For optimal performance and safety, review the following:
Do not load other software onto the programmer. Doing so may interfere with the efficiency and function of
the pre-installed VNS Therapy Software.
The programmer is tested to the same level as typical consumer electronic devices. However, the equipment
is not rated for use in the patient environment (as defined by IEC 60601-1). Do not simultaneously touch the
patient and programmer while programming. Additionally, do not plug the programmer into AC power while
it is being used in a patient environment.
Warning: Do not connect unapproved equipment. Doing so can damage the system and/or cause
injury.
Warning: Do not modify the system unless directed to by LivaNova.
Warning: Use of accessories, transducers and cables other than those specified or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided
because it could result in improper operation. If such use is necessary, this equipment and the other
equipment should be observed to verify that they are operating normally.
Warning: Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the Wand, including
cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment
could result.
Warning: MR Unsafe devices include the programming wand, computer, and patient magnet. Theses
devices must not be brought into the MR scanner room.
Warning: Safeguard the VNS Therapy Programming System against theft. Theft could lead to
malicious activities against the System.
9 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
a. Programmer
b. AC Power Adapter
c. Wand
d. Wand USB Cable
3. GET START ED
3.1. Parts Included
The system includes the following items (Figure 1):
Touch-screen Programmer preloaded with the VNS Therapy Software
A/C power adapter
Wand model 2000 with two AA batteries
Backup wand USB cable
Figure 1. System Parts
If preparing for use in a sterile field, follow aseptic practices. Each part of the Programming System is
designed to fit inside commonly available sterile covers (e.g. laser/camera arm drapes). LivaNova
recommends using one sterile cover for each Programming System part.
If any parts of the system are missing, contact LivaNova.
3.2. Prepare System for Use
Before using the programming system in a patient session, make sure the programmer and wand are
fully charged and ready to use. Verify the date and time on the programmer are correct.
3.3. Basic Operation
3.3.1. Charge the Programmer
To charge the programmer, connect the AC adapter and plug into an outlet (see figure below). Charge
the programmer when not in use so that there is enough battery power when using during a patient
session.
10 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
Figure 2. Connect the Charger
3.3.2. Turn Programmer ON/OFF
To turn on the programmer, press and hold the power button for 3 seconds and then release (Figure 3).
A few seconds after releasing the power button, you will see an on-screen logo, followed by automatic
startup of the VNS software.
Figure 3. Power On Programmer
To turn off the programmer, press and hold the power button for 3 seconds and then release. Follow
on-screen instructions to shut down the programmer.
Note: The power button may not respond if the programmer is still shutting down.Wait for 30 seconds
after a shut down to restart the programmer.
3.3.3. Turn the Programmer Screen ON/OFF
Once the programmer is turned on, the screen will automatically turn off after 5 minutes of inactivity.
You can also turn the screen on or off by quickly pressing and releasing the power button. Use this
method when you want to preserve battery, but not shut down the programmer.
11 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
Select time to adjust time
Select day on calendar to adjust date
3.3.4. Check Programmer Battery
After VNS software startup is complete, the programmer battery status can be checked at any time by
viewing the indicator at the top right corner of any software screen. For more information, refer to
“How to Use the Software” on page 19.
3.3.5. Set the Programmer Date and Time
Accurate patient and device history stored in the programmer depends on correct time and date
settings. To adjust the date and time, select Settings from the bottom navigation bar, then Programmer
settings, and Date & Time. You can adjust the time by tapping the current display and scrolling up or
down. To change the date, use the left or right arrow to adjust the calendar, and then tap the desired
date. When finished, choose Save Changes. See Figure 4.
Figure 4. Adjust Programmer Time and Date
Note: The programmer does not automatically adjust for Daylight Saving Time or changes in time
zone. Adjust the time and date manually as needed.
3.3.6. Turn on Wand/Check Wand Battery
Turn the wand on by pressing and releasing the power button (Figure 5). If the battery is OK, green
lights will illuminate (Figure 6). If the battery is low, the low battery indicator will illuminate (Figure 7). If
the battery is low, replace the batteries by removing the cover located on the back of the wand
(Figure 8).
12 of 58 — 26-0009-7500/0 (OUS)
Figure 5. Power On Wand
Figure 6. Power Indicator (Battery OK)
Physician’s Manual — VNS Therapy Programming System
Figure 7. Low Battery Indicator
13 of 58 — 26-0009-7500/0 (OUS)
Figure 8. Wand Battery Replacement
Push and slide to open battery compartment
Bottom of Wand
Note: Once powered on, the wand will automatically power down (standby) after 60 seconds of
inactivity to conserve battery.
3.4. Connect Wand/Programmer
Physician’s Manual — VNS Therapy Programming System
The system allows you to connect the wand to the programmer wirelessly or with backup USB cable.
To connect wirelessly, you have two options:
Set up a preferred wand connection that is always used with that programmer. This setup is recommended
for wands and programmers that are always used together. It provides a quicker connection when
interrogating the patient's generator, since the programmer will automatically look for the preferred wand.
Choose a wand as part of interrogating the patient's generator. This method is recommended if you have
several interchangeable programming systems in your area. When interrogating a patient's generator, the
programmer will search for all available wands in range.
3.4.1. Preferred Wireless Wand Setup
To set up a preferred wireless connection between the wand and the programmer, do the following:
1. Power on the programmer
2. Select Settings from the bottom navigation bar
3. Power on the wand
4. Select the Wand Settings menu option, and enable the Preferred wand selection (while the wand is powered
on)
5. Select the desired wand serial number. Once connected, the software will show this serial number as your
preferred wand.
6. Use the back button (upper left) to return to the Main screen
3.4.2. Wired Wand Setup
Included with the system is a USB cable that connects the wand to the programmer. Use this as a back
up method when a wireless connection is not available. Once connected, the software will identify the
specific wand connected via the cable. After interrogate is selected, the four green indicators will light
up once the wand begins communicating with the generator. The green indicator lights will turn off
after 60 seconds of inactivity.
14 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
4. INTERROGATING THE GENERATOR
4.1. Interrogate (No Preferred Wand)
You must interrogate the generator before performing other functions, such as applying new
parameters or performing diagnostics tests.
To begin, power on the programmer. Upon startup, the Main screen will display (Figure 9).
Figure 9. Main Screen
Next, turn on the wand by pressing and releasing the power button. Two green lights will illuminate
indicating the wand is ready to connect. While the green wand lights are illuminated (Figure 6), select
Interrogate on the programmer screen. The programmer will search for available wands. See Figure 10.
15 of 58 — 26-0009-7500/0 (OUS)
Figure 10. Wand Search Screen
SN location on back of Wand
ba022
Physician’s Manual — VNS Therapy Programming System
The programmer will show all powered-on wands in range. Select the wand you intend to use
(Figure 11), using the wand serial number (SN). The wand SN is located on the back of the wand.
Figure 11. Wand (SN) Selection Screen
Note: To use a specific want in subsequent sessions, check the “Automatically connect to the same
wand every time” box on the screen before choosing a wand.
Once the wand has connected, the software will indicate a successful connection and four green lights
will illuminate around the wand power button (Figure 12).
16 of 58 — 26-0009-7500/0 (OUS)
Figure 12. Successful Wand Connection
Successful wand connection lights illuminated
Generator icon will flash during interrogation
Physician’s Manual — VNS Therapy Programming System
Place the wand over the generator as shown on the software (Figure 13). Once the wand recognizes the
generator, the interrogation will complete and the software will display the summary screen. For more
details refer to “How to Use the Software” on page 19.
Figure 13. Interrogate Generator Screen
4.2. Interrogate (With Preferred Wand)
If you have set up a preferred wand, the programmer will automatically connect to that wand when you
press Interrogate.
17 of 58 — 26-0009-7500/0 (OUS)
Physician’s Manual — VNS Therapy Programming System
The main screen will display to the preferred wand information. See Figure 14. Make sure wand is
powered on before selection interrogate. After the programmer and wand are connected, place the
wand over the generator to complete the interrogation.
Figure 14. Main Screen - Preferred Wand
4.3. Interrogate (Change Preferred Wand)
If you have set up a preferred wand, but want to connect to a different wand, perform the following
steps:
1. Power on the new wand
2. Select the Change button on the Main Screen.
The programmer will search for all wands that are powered on and in range. Select the intended wand
serial number from the list. When you connect to the new wand, it will become the new preferred wand
and the programmer will automatically connect to it in future sessions. Place the wand over the
generator to complete the interrogation.
Note: To clear the preferred wand and connect manually, select Settings from the Main screen. Within the
Wand Settings, set the Preferred Wand status to Disabled. Select the back button on the upper left of the
screen to return to the Main screen. Next time you interrogate, manually connect to a wand following the
steps in “Interrogate (No Preferred Wand)” on page 15.
18 of 58 — 26-0009-7500/0 (OUS)
Loading...