VNS Therapy System Overview and Dosing - Dubai · VNS Therapy™System Overview and Dosing...

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VNS Therapy™ System Overview and Dosing

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Course Outline• Product Overview

• Basic parameters and dosing

• Programming System set up

• Model 102/102R• Dosing

• Diagnostics

• End of Service

• Common error messages

• Model 103/104• Dosing

• Diagnostics

• End of Service

• Common error messages

• Summary of differences

• Misc. Software Features

• Lessons Learned

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VNS Therapy System Components• VNS Therapy Generators:

• Pulse Model 102/ Pulse Duo 102R Pulse Generator

• Demipulse Model 103/ Demipulse Duo 104 Pulse Generator

• Model 100, Model 101 (no longer distributed)

• Handheld Computer – Dell Axim X50

• VNS Therapy Programming Wand Model 201

• VNS Therapy Model 250 Programming Software Version 7.1

• Model 220 Magnets (Patient Kit)

• Leads

• Model 302 and 303 Lead (distributed)

• Model 300 (no longer distributed)

• Surgical Components (n/a for clinic setting)

• Model 402 Tunneler

• Model 502 Accessory Kit

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Pulse Generators

Location

• Subcutaneously in left chest

Purpose

• Delivers electric pulses at programmed time intervals

• Stores selected information

• Model 102 and 103 (Single Pin receptacle)

• Model 102R and 104 (Dual Pin receptacle)

Pulse

Model 102

Pulse Duo

Model 102R

Demipulse

Model 103

Demipulse Duo

Model 104

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Programming System Components

Handheld Computer• Platform for Programming

Software

• Always keep charged when not in use

Programming Wand• Accessory to programming

handheld computer

• Communication tool between Programming Software and Pulse Generator

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VNS Therapy Leads

Lead Model 302

Perennia Model 303

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VNS Therapy Patient Magnets –Inhibit Stimulation (all indications)

Location• Patient’s wrist or belt

Purpose• Temporarily turn off the device to alleviate

possible side-effects (due to stimulation parameters)

Use• Hold over device to immediately stop

stimulation

• Keep in place for 65 seconds or greater

• After at least 65 seconds and when removed, stimulation resumes after one complete OFF-time period

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VNS Therapy Patient Magnets-On Demand Stimulation (Epilepsy Only)

Location• Patient’s wrist or belt

Purpose• To provide on-demand

magnet mode stimulation before or at an onset of a seizure

• Can also be used to test device daily to ensure battery is functioning properly

Details• Magnetic field of at least 50

Gauss at 1 inch

• Apply or pass the Magnet over the Pulse Generator for >1 sec and <65 sec will result in magnet mode stimulation

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BASIC PARAMETERS AND DOSING

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Parameters – “NORMAL MODE”

m

Parameter Units Range

Output Current Milliamps (mA) 0 - 3.5

Signal Frequency Hertz (Hz) 1 - 30

Pulse Width Microseconds ( sec) 130 - 1000

Signal On-time Seconds (sec) 7 - 60

Signal Off-time Minutes (min) 0.2 - 180

Pulse Generator Dosing Parameters

Stimulation throughout the day (24 hours/day, 7

days/week) is referred to as the “Normal Mode”

Stimulation

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Parameters – “MAGNET MODE”

Parameter Units Range

µ

Magnet Output Current Milliamps (mA) 0 - 3.5

Magnet Pulse Width Microseconds ( sec ) 130 - 1000

Magnet On-timeSeconds (sec) 7 - 60

Pulse Generator Dosing Parameters

The magnet output current will always be set to 0 mA for

patients diagnosed with Treatment-Resistant Depression

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Parameters – “Dose”

Pulse Width (µsec)

Output Current (mA)

Signal Frequency (Hz)

Output Current – Amount of electrical current delivered in a single pulse of

stimulation.

Pulse Width – Duration of a single pulse within a stimulation period

Signal Frequency – Number of pulses per second; measured in Hertz

1

4

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Parameters – “Dose” Adjustment

Adjusting Output Current alone.

1 mA 2 mA

250 msec 500 msec

Adjusting Pulse Width alone.

20 Hz 30 Hz

Adjusting Signal Frequency alone.

Patient 2Patient 1

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Parameters – “Timing”

Ramp Up – Gradual increase in output current over approximately two

seconds at the beginning of stimulation.

Ramp Down – Gradual decrease in output current over approximately

two seconds at the end of stimulation.

Ramp Up Ramp Down(2 sec.) (2 sec.)

On Time

Stimulation Time

Off Time

Pulse Width

Output Current

Signal Frequency

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Parameters – “Timing - Duty Cycle”Calculation

OFF TIME (Minutes)ON TIME (Seconds) 0.2 0.3 0.5 0.8 1.1 1.8 3 5 10

7 58 44 30 20 15 10 6 4 2

14 69 56 41 29 23 15 9 6 3

21 76 64 49 36 29 19 12 8 4

30 81 71 57 44 35 25 16 10 5

60 89 82 71 59 51 38 27 18 10

Duty cycle (%) = On Time (sec) + Off Time (sec)

On Time (sec) + 4 seconds X 100

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PROGRAMMING SYSTEMSet-up

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Dell AXIM x50 Dosing System Set-up

Stylus

Flash Card Slot Handheld Computer

Serial Cable

A/C Adapter

Notice: Only 1

connection into

Handheld

Model 201 Programming Wand

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Getting StartedWand Check

• Briefly press and release the two red “Reset” buttons

• Check illumination time of green “Power Light”

• Illumination > 25 seconds indicates sufficient battery life

• Illumination < 25 seconds, replace 9 Volt Battery

Power LED

Reset Buttons

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Getting StartedHandheld

• Turn Handheld ON

• Place Programming

Wand over patient’s

generator ( 1 inch

away)

ON/OFF

Pulse Model 102/102R Generator: Dosing

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Typical Dose Adjustment Session

1. Interrogate generator

2. Adjust parameters if desired, based on efficacy,

outcome and paying attention to patient’s tolerability

3. Program parameters

4. Always interrogate generator as last step in session

– Ensures parameters are programmed as desired

System and Normal Mode Diagnostics steps will be

added to dose adjustment sessions once minimum

stimulation parameters are achieved

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Step 1 – “Interrogate Device”

• Interrogation is

always the first and

last step in a

programming

session

• From “Main Menu”,

select “Interrogate

Device”

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Step 1 – “Interrogate Device”(cont.)

• With wand properly placed over the generator, select “Start Interrogation”

• Allow time for completion

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Step 2 – “Selecting Parameters”

Tap the “New” button

for the parameter you

want to change.

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Step 2 – “Selecting Parameters”(cont.)

Tap the desired value

Use scroll buttons to view more selections

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Step 3 – “Programming”

• Select “Program” then “Start Programming.”

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Step 3 – “Programming”(cont.)

NOTE: After completion the device will stimulate the patient as programmed.

Note: For patients with depression, the pulse generator’s magnet mode output should remain at 0 mA

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Step 4 – “Final Interrogation”(cont.)

•Check parameters are programmed as desired, then,

•Select “Menu” followed by “Main Menu”, and turn handheld “Off”.

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Example of Titration ProcessParameter Step #1 Step #2 Step #3

Output current 0.25 0.5 0.75

Signal

Frequency

20/30 20/30 20/30

Pulse Width 250/500 250/500 250/500

Signal ON Time 30 30 30

Signal OFF Time 5 5 5

Magnet Output

Current

.5

(0 mA for TRD)

.75

(0 mA for TRD)

1.0

(0 mA for TRD)

Magnet Pulse

Width

500 500 500

Magnet Signal

ON Time

60 60 60

Step #3 – diagnostic tests should be routinely performed when the output current

reaches 0.75mA and greater PHPT05-11-6002

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Example of Titration Process: cont.Parameter Step #4 Step #5 Step #6


Signal

Frequency

20/30 20/30 20/30

Pulse Width 250/500 250/500 250/500



Magnet Output

Current

1.25

(0 mA for TRD)

1.5

(0 mA for TRD)

1.75

(0 mA for TRD)

Magnet Pulse

Width

500 500 500

Magnet Signal

ON Time

60 60 60

Step #3 – diagnostic tests should be routinely performed when the output current

reaches 0.75mA and greater

Pulse Model 102/102R Generator: Device

Diagnostics

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Normal Mode Diagnostics: Model 102/102R

• Normal Mode Diagnostic –To assess the

deliverability of the normal mode output current.

• Minimum settings:

• Output Current 0.75 mA

• Signal Frequency > 10 Hz

• ON Time 30 seconds

• Recommend perform at every office visit once patient

can tolerate minimum settings (see above)

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System Diagnostics:Model 102/102R

Purpose:

Tests the VNS system’s connection to the patient and integrity of the VNS Therapy Lead

• Automatically programs the device to the following settings: 1 mA, 20 Hz, 500 msecs, 30 sec ON, and 60 min OFF, then returns the device to its original “Normal Mode “ parameters

• Recommend perform at every office visit (pending patient’s tolerance of settings listed above)

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OTHER DIAGNOSTICS

Generator Diagnostics

Only used to troubleshoot in the operating room on the day of implant. DO NOT use for Follow-up visits.

Magnet Mode Diagnostics

(For patients with Epilepsy)

Tests the system’s magnet mode functionality in the same way as the Normal Mode, but with the use of the magnet to initiate the test.

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4. Perform System and Normal Mode Diagnostics


– Ensures parameters are programmed as desired

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Perform “Normal Mode Diagnostics”

• Confirm device settings

meet the requirements

for this test

•Minimum requirements:

•Output Current 0.75 mA

•Signal Frequency > 10 Hz

•ON Time 30 seconds

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• Select “Menu”

• Select “Device Diagnostics”

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• Select “Other Diagnostics”

• Select “Normal Mode Diagnostics”

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• Place programming wand over generator, select

“OK.”

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Normal Mode DiagnosticsRESULTS

Output Status:

• If “OK” - Programmed

current is being delivered

• If “LIMIT” – Programmed

output current is NOT being

delivered

DC DC Converter:

• Ranges from 0-7

• DCDC 7 typically coincides

with a “LIMIT” Output Status

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Comparison of Possible ResultsNORMAL MODE DIAGNOSTICS

Implanted mm/dd/yy

Communication OK

Output Status OK

Output Current 2.0ma

Lead Impedance OK

DCDC Converter 5

Near End of Service NO

Implanted mm/dd/yy

Communication OK

Output Status LIMIT


Lead Impedance HIGH

DCDC Converter 7


Output current being delivered Output current not being delivered

See troubleshooting section for “High Lead Impedance on a diagnostic Test at

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Perform “System Diagnostics”

• Select “Menu”

• Select “Device Diagnostics”

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Perform “System Diagnostics”

• Choose “System Diagnostics” from the Diagnostics Menu of options.

• Place programming wand over device, select “OK.”

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System DiagnosticsRESULTS

Lead Impedance: OK• If “OK” integrity of the system is WNL

• DCDC (0-3) coincides with “OK” impedance.

Lead Impedance: HIGH• If “HIGH” lead impedance is higher

than expected

• DCDC (4-7) coincides with “HIGH” impedance conditions (e.g. fibrosis or lead break)

Output Status:• If “OK” – 1mA current is being

delivered

• If “LIMIT” – 1mA current is NOT being delivered

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Comparison of Possible ResultsSystem Diagnostics

Implanted mm/dd/yy

Communication OK

Output Status OK


Lead Impedance OK

DCDC Converter 3


Implanted mm/dd/yy

Communication OK

Output Status LIMIT


Lead Impedance HIGH

DCDC Converter 7


1 mA being delivered Typical discontinuity results


Follow-Up Visit” in Physician’s Manual for recommendations and course of actionPHPT05-11-6002

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Suspected Lead Breaks

• If diagnostics suggest that a fracture is present, consider turning the VNS Pulse Generator to zero milliamps (0 mA) of output current.

• Continuing stimulation with a fractured Lead may result in dissolution of the conductor material resulting in…• Pain

• Inflammation

• Vocal Cord dysfunction

• Risk/Benefit of leaving “On” should be evaluated and monitored by the treating medical professional.

Pulse Model 102/102R Generator: End of Service

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End of Service (EOS): 102/102RClinical Indicators of potential EOS

Increase in seizure activity

Painful or erratic stimulation

Report of decreased perception of stimulation or no stimulation when performing daily magnet activation

If EOS has been reached, the pulse generator will not deliver any output, the patient will not feel stimulation, attempts to interrogate will be unsuccessful

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End of Service (EOS): 102/102R

Elective Replacement Indicator (ERI):

• Upon Interrogation, if the ERI is set to YES, this message will be displayed.

• The ERI should be used as the primary indicator of nearing EOS.

• The time from ERI to EOS is highly dependent on the programmed parameters and the Lead impedance.

• Note: Model 100B generators (distributed prior to 1999) do not have the Elective Replacement Indicator function

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End of Service: All Diagnostics(102/102R)

• Each diagnostic test will provide

the ERI, “Near End of Service”.

• “NO” indicates the device is NOT

nearing “End of Service” at this time

.

• “YES” indicates the device is

nearing “End-of–Service”. Prompt

replacement may help minimize any

possible relapse in

seizures/depressive symptoms.

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End of Service Summary: 102/102R

For help in determining generator battery life, please contact Clinical Technical Support at 866-882-8804 with the patient’s complete parameter history and latest System Diagnostic test results

If longevity of the generator is shorter than expected, contact Clinical Technical Support at 866-882-8804

Pulse Model 102/102R Generator: Common Errors

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Output Warning

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Common Diagnostic Errors: 102/102R

Communication problems during a diagnostic test can result in

the following messages

See Troubleshooting Section in Physician’s Manual for recommendations and course

of action

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Common Interrogation Errors

Communication problems during an interrogation can

result in the following messages


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Solutions to Common Errors

Be sure the handheld computer is fully charged and is

not plugged into a wall outlet.

Test the batteries in the programming wand.

Make sure the programming wand is directly over the

pulse generator.

Check all cables and connections to ensure they are

properly connected.

Rule out an EMI (electromagnetic interference).

If these steps do not address the problem, call

Cyberonics Clinical Technical Support Team at

(866) 882-8804

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“Cross-Programming”

What is it?

Cross programming one patient’s settings to another patient’s device without interrogating the second patient’s device first. There have been a few incidences of cross-programming reported recently.

When does it occur?

If the patient previously interrogated has the same model number generator and the software is left on either the “program new parameters” screen or a diagnostic testing screen.

What will happen?

The programming event will appear in the programming software as if it was performed on the first patient, though it was actually performed on the second patient.

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“Cross-Programming”

What can be done to prevent cross-programming?

Always Interrogate as the first and last step

Set Inactivity Time-out to a lower value (3 min, 5 min, or 10 min) for Prescribing Physician Handheld

Pulse Model 103/104 Generator: Dosing

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4. Perform System Diagnostic Test


– Ensures parameters are programmed and delivered as

desired

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Step 1 – “Interrogate Device”

• Interrogation is

always the first and

last step in a

programming

session

• From “Main Menu”,

select “Interrogate

Device”

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Step 1 – “Interrogate Device”(cont.)

• With wand properly placed over the generator, select “Start Interrogation”

• Allow time for completion

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Step 2 – “Selecting Parameters”

Tap the “New” button

for the parameter you

want to change.

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Step 2 – “Selecting Parameters”(cont.)

Tap the desired value

Use scroll buttons to view more selections

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Step 3 – “Programming”

• Select “Program” then

“Start Programming.”

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Step 3 – “Programming”(cont.)

NOTE: After completion the

device will stimulate the

patient as programmed.

NOTE: For patients with

depression, the pulse

generator’s magnet mode

output should remain at 0 mA

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Step 4 – “Final Interrogation”(cont.)

•Check parameters are programmed and delivered as desired, then,

•Select “Menu” followed by “Main Menu”, and turn handheld “Off”.

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Example of Titration ProcessParameter Step #1 Step #2 Step #3


Signal

Frequency

20/30 20/30 20/30

Pulse Width 250/500 250/500 250/500



Magnet Output

Current

.5

(0 mA for TRD)

.75

(0 mA for TRD)

1.0

(0 mA for TRD)

Magnet Pulse

Width

500 500 500

Magnet Signal

ON Time

60 60 60

A System diagnostic tests should be routinely performed at each dosing

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Example of Titration Process: cont.Parameter Step #4 Step #5 Step #6


Signal

Frequency

20/30 20/30 20/30

Pulse Width 250/500 250/500 250/500



Magnet Output

Current

1.25

(0 mA for TRD)

1.5

(0 mA for TRD)

1.75

(0 mA for TRD)

Magnet Pulse

Width

500 500 500

Magnet Signal

ON Time

60 60 60

A System diagnostic tests should be routinely performed at each dosing

Pulse Model 103/104 Generator: Device

Diagnostics

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Automatic Lead Impedance Measurement

Once every 24 hours a lead impedance measurement is taken. If the impedance

has reached “High” or “Low” between interrogations (office visits), a warning

message similar to the one above will be displayed upon interrogation of device.

Impedance value will

display the true

impedance between 7000

Ohms and >10000 Ohms

if “High,” and <200 Ohms

if “Low.”

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4. Perform System Diagnostic Test


– Ensures parameters are programmed and delivered as

desired

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System Diagnostics: Model 103/104

System Diagnostic – Evaluates the Lead

impedance of the VNS system as well as the

pulse generator’s ability to deliver the

programmed stimulation.

Recommended at every office visit.

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System Diagnostic for Demipulse Model 103/104

When output current is > 0 mA (e.g. Follow-up)1. Short 0.25 mA, 130 msec pulse (Assess Impedance)

2. Followed by ANY programmed parameters (Assess Output Current)

When output current is = 0 mA (e.g., in OR) :1. Short 0.25 mA, 130 msec pulse (Assess Impedance)

2. Followed by 1.0 mA, 20 Hz, 500 msec parameters (Assess Output Current)

Note – Automatic System Diagnostic (one per 24 hours) is not performed

when the Demipulse is programmed to 0mA

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System Diagnostics: Follow-up

103 / 104

0.5 mA

Stim @ 0.5 mA

0.25 mA, 130 m sec Impedance Measurement Pulse

0.5 mA 0.5 mA

Results

The System Diagnostic assesses both the Lead

Impedance and the Output Current for 103 and 104

All programmable settings are allowed

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Assessing Lead Impedance Model 103/104

Focus on “Lead Impedance” and

“Impedance Value”

> 7000 ohms is “High” impedance for

Demipulse Model 103 and 104

> 10,000 ohms is indicative of a

discontinuity or break

< 200 ohms is “Low” impedance for

Demipulse Model 103 and 104, could

also indicate a break or short circuit

NOTE: In this example, 0.5 mA was

programmed as the output current

prior to diagnostics.

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Assessing Output Current Model 103/104

Focus on “Output Current” and

“Current Delivered”

Output current should be “OK”

If “LOW”, then “Current Delivered” ≠

Programmed Current

NOTE: In this example, 0.5 mA was

programmed as the output current

prior to diagnostics.

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Model 103/104 Comparison of Possible ResultsSystem Diagnostics

Implanted mm/dd/yy

Communication OK

Output Current OK

Current Delivered 1.0 mA

Lead Impedance OK

Impedance Value 3000

ohms

End of Service “x” yrs

Implanted mm/dd/yy

Communication OK

Output Current LOW

Current Delivered 0.0ma

Lead Impedance HIGH

Impedance Value 10000

ohms

End of Service “x” yrs

1 mA being delivered Typical discontinuity results


Follow-Up Visit” in Physician’s Manual for recommendations and course of action

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System Diagnostics

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Suspected Lead Breaks

• If diagnostics suggest that a fracture is present, consider turning the VNS Pulse Generator to zero milliamps (0 mA) of output current.

• Continuing stimulation with a fractured Lead may result in dissolution of the conductor material resulting in…• Pain

• Inflammation

• Vocal Cord dysfunction

• Risk/Benefit of leaving “On” should be evaluated and monitored by the treating medical professional.

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OTHER DIAGNOSTICS

Generator Diagnostics

Only used to troubleshoot in the operating room on the day of implant. DO NOT use for clinic follow-up visits.

Magnet Mode Diagnostics

(For patients with Epilepsy)

Tests the system’s magnet mode functionality in the same way as the Normal Mode, but with the use of the magnet to initiate the test.

Pulse Model 103/104 Generator: End of Service

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End of Service (EOS): 103/104Clinical Indicators of potential EOS

Increase in seizure activity

Painful or erratic stimulation

Report of decreased perception of stimulation or no stimulation when performing daily magnet activation

If EOS has been reached, the pulse generator will not deliver any output, the patient will not feel stimulation, attempts to interrogate will be unsuccessful

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Generator Battery Life Projection

The Demipulse Model 103 and 104 have the ability to project battery life based on time of implant and programmed settings.

Each generator’s software monitors battery depletion.

Upon interrogation, warning messages are displayed by the handheld software when the generator battery life is approaching or is past the projection for end of service.

All VNS Pulse Generators eventually require surgical replacement as a result of battery depletion.

Pulse Generator replacement does not, of itself, require Lead replacement unless a Lead discontinuity (break) is suspected.

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Instant update to End of Service Projection when new device settings are

chosen. Projection will update over time as well.

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Generator Near End of Service Warning

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Generator Past End of Service Warning

At this point the generator may or may not be delivering stimulation as intended.

Pulse Model 103/104 Generator: Common Errors

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Output Warning

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Common Diagnostic Errors

Communication problems during a diagnostic test

can result in the following messages


of action

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Common Interrogation Errors

Communication problems during an interrogation can

result in the following messages


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Solutions to Common Errors

Be sure the handheld computer is fully charged and is

not plugged into a wall outlet.

Test the batteries in the programming wand.

Make sure the programming wand is directly over the

pulse generator.

Check all cables and connections to ensure they are

properly connected.

Rule out an EMI (electromagnetic interference).

If these steps do not address the problem, call

Cyberonics Clinical Technical Support Team at

(866) 882-8804

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Summary of Differences: Previous Pulse Generators

vs. 103/104

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VNS Therapy Pulse Generators Comparison

Size Comparison of the Model 103 vs. the Model 102

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Model 103 / 104 Enhancements

Feature Benefit


System

Remaining generator battery life projected and

displayed to assist with End of Service decision

process.

Generator Battery Life Warning

Message

Displayed when battery life is within 6 months of

the end of life projection to assist with End of

Service decision process.

Smaller Size Improve post implant cosmetics.

Direct Lead Impedance Measurement No more DCDC codes. Impedance is measured

directly and displayed to clinician to give

accurate measurements (ohms).

Automatic Lead Impedance

Measurement Once Every 24 Hours

Warning message notification to clinician upon

interrogation if impedance is “High” or “Low.”

Quicker Communication Faster patient dosing and diagnostics.

Parameter Retention Settings are not lost if generator is reset.

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Generator Evolution

The Demipulse Model 103 and 104 have a 48% reduction in Generator

thickness and a 74% reduction in Generator volume compared with

the Model 100, which has improved post implant cosmetics.

Model 101

0.41” (10.3 mm)

26 cc

Model 102/102R

0.27” (6.9 mm)

14/16 cc

Model 103/104

0.27” (6.9 mm)

8/10 cc

Model 100

Thickness: 0.52” (13.2 mm)

31 cc

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VNS Therapy Pulse Generators Comparison

Generator Model 102 102R 103 104

Matching Lead Type Single Pin Dual Pin Single Pin Dual Pin

Launch Year 2002 2003 2007 2007

Thickness 7 mm 7 mm 7 mm 7 mm

Volume 14 cc 16 cc 8 cc 10 cc

Weight 25 gms 27 gms 16 gms 17 gms

Battery Life* 6+ yrs 6+ yrs 6+ yrs 6+ yrs

Computer Platform Handheld/

Laptop

Handheld/

Laptop

Handheld

ONLY

Handheld

ONLY

Software 6+ 6+ 7+ 7+

*Predicted longevity at 2mA, 20Hz, 500µS, 10% duty cycle into a 4kOhm load. The dose settings impact how long the

battery will last. For example, the battery may last for 3 years at a higher setting, compared with 8 years at a lower

setting. For the full range of settings in relationship to battery life, see the Physician's Manual or the EOS Projection on

the Handheld.

Miscellaneous Software Features

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Programming Software Features

• Adjusting Date and Time

• It is very important that the date and time on the handheld are correct. All

historical programming data is stored using the handheld date and time.

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Inactivity Timeout Feature

• Time Stamp

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Inactivity Timeout Warning

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• Capability to view and print programming history

database in an Excel spreadsheet

• Equipment needed:

• Flashcard Reader – Not provided by Cyberonics

• Technical support for the Flashcard Reader is not

provided by Cyberonics

• Personal PC – Not provided by Cyberonics

Database Utility Feature

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• Located on the User Preferences Screen

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• Exporting Files

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1. Remove Flashcard from Handheld

Computer

2. Insert flashcard into a flashcard reader

connected to a desktop computer

3. Open files PIExport, DiagExport, and

MagExport in Microsoft Excel

1

2


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Programming Software Features

• View Database – Patient does not need to be present to perform “View Database”

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View DatabaseVIEW PARAMETER HISTORY

• Select “View Parameter History”

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View DatabaseVIEW DIAGNOSTIC HISTORY

• Select “View Diagnostic History”

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View DatabaseVIEW MAGNET HISTORY

• Select “View Magnet History”

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Parameters Screen Menu

• Select “Standard Settings” sets Output current to 0 mA and other predetermined parameters.

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Program Patient Data

• Program Patient Data – Allows user to enter patient ID and Implant Date. Should be performed in the OR.

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Display Device History

• Display Device History – Allows user to view stored pulse generator information

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Handheld Battery ChargeKeep your handheld computer plugged in at all times when not in use

“PC Power Remaining” status bar indicates charge remaining on handheld computer

Parameters Screen Menu User Preferences Screen

Miscellaneous Handheld Features

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Soft Reset

Press Reset button with Stylus for 5 seconds

Perform during screen freeze

Reset

button

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Hard ResetPress Power button and Reset button simultaneously

Perform only when soft reset does not resolve a screen freeze

Reset

button

Power

button

Contacts

button

Note:

When

prompted,

select the

Contacts

button

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Hard Reset

If the handheld computer has not been

plugged in to an AC power for a period

of time, the battery charge will

completely deplete. When you plug in

the AC power cord, the handheld

computer will go through a hard reset.

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Hard Reset

• Steps during hard reset

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Hard Reset


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Hard Reset


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Align Screen

Press both buttons together to align screen

Power button

Select button

Note: This screen align is

not associated with a soft

or hard reset. The screen

align should be used to

voluntarily align the screen

when the screen is not

aligned.

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Lock Button

Lock button located on left side

Should remain in the UNLOCK position at all

times

Handheld is in the

unlocked position with

the button down

Handheld is locked,

move button down

to unlock

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Proper Handling of the VNS Programming System

• The VNS Therapy Programming System is designed to

withstand normal wear and tear conditions for electronic devices

• Do not subject the Programming System to rough handling or

abuse

• Do not pull on data cables

• If adaptor cable must be disconnected from the Handheld, grasp

the connector firmly and pull the adapter out

• Do not store or operate the Programming System with sharp

bends in the data cables or adaptors.

• Avoid coiling cables into small diameters

Lessons Learned

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Having a clear understanding of the parameters will lead to intended dose adjustments.

Always Interrogate as the FIRST and LAST step at every visit.

Keep your Handheld computer plugged in at all times when not in use

Always check the battery in the wand prior to use and keep a backup 9 Volt battery if necessary

Pay close attention to all warning, error, and fault messages

Routine diagnostic testing can prove beneficial in the long term

The Technical Guide and Physician’s Manual are valuable tools for any questions, concerns, and troubleshooting

Lessons Learned

VNS Therapy System Overview and Dosing - Dubai · VNS Therapy™System Overview and Dosing...

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Transcript of VNS Therapy System Overview and Dosing - Dubai · VNS Therapy™System Overview and Dosing...