Troubleshooting

LOW Impedance

A $LEADIMPEDANCE: ($ZVALUE:) lead impedance has been detected. This could indicate a possible discontinuity of the lead, or fibrosis between the nerve and the lead, or other problems. If you have questions, please consult the Physician’s
Manual or contact Cyberonics.

Note: $ZVALUE: can be one of the following:

• For values >= 7000 Ohms and < 10000 Ohms, $ZVALUE: will be the measured value.
• For values >= 10000 Ohms, $ZVALUE: will be “>= 10000”.

(14) or (16)

(21)

An invalid serial number or generator reset has been detected. If you know the serial number of the generator enter it now. The serial number must be in the range of $RANGE:

Reference Troubleshooting Option # (4) for “$RANGE” values.

Programming Settings/Generator Status

Data Storage

Programming Settings

Communication

Diagnostic Failed. The generator parameters were potentially reprogrammed to unintended settings.Try the following and select Retry.

• Unplug the handheld from the power outlet
• Check the wand battery
• Reposition the wand over the generator

Communication

(5) and (6)

(5)

Programming Settings

HIGH Impedance

HIGH Impedance

(21)

LOW Impedance

(25)

HHD Configuration

HHD Status

Programming Settings

(12)

LIMIT Status

LIMIT Status

(14), (15), or (16)
if detected with a High
impedance (5) all other
cases, then reperform
diagnostic testing

LIMIT Status

Data Storage

HHD Status

(5)

Programming Settings

(5)

The Generator settings were altered due to an interrupted programming attempt. Try the following and select Retry.

• Unplug the handheld from the power outlet
• Check the wand battery
• Reposition the wand over the generator

Communication

(5) and (12)

Communication

Generator Status

(13)

(18)

Programming Settings

Generator Status

(5)

(5)

Generator Status

Diagnostic Technique

Programming Settings

(5)

Generator Status

Generator Status

(19)

Generator Status

(13)

Programming Settings

(5)

HHD Configuration

(5)

HHD Configuration

(5)

Programming Settings

(26)

Communication

(6)

Programming Settings

You are only allowed to view $DBLIMIT: records at a time. You should narrow your selection using Date, Serial Number,
or Patient ID criteria. Note: $DBLIMIT: can be one of the following:
25
50
75
100

HHD Configuration

(5)

Programming Settings

Perform a hard reset:

For Dell x5 (applies to both PPC 2002 and PPC 2003 OS)
1) Plug the HHD into an appropriate power source;
2) Press and hold both the “Power” button and the “Reset” button (on the side of the HHD) for at least 5 seconds;
3) Select “Yes” to clear all data when prompted;
4) Complete the screen alignment, Windows tutorial, and set the date and time upon request;
5) Unplug the HHD from its power source once the VNS software has loaded and continue with session.

For Dell x50
1) Plug the HHD into an appropriate power source and verify that the Screen Lock button on the side of the HHD is not set;
2) Press and hold both the “Power” button and the “Reset” button (on the back of the HHD) for at least 5 seconds;
3) Select “Yes” to clear all data when prompted;
4) Complete the screen alignment, Windows tutorial, and set the date and time upon request;
5) Unplug the HHD from its power source once the VNS software has loaded and continue with session.

Perform the following communication troubleshooting:

1) Verify that the HHD is not plugged into a wall outlet. If it is, unplug the HHD and attempt communication again. If communication is still unsuccessful, proceed to Step 2;
2) Test the wand battery by pressing and releasing both “Reset” buttons at the same time. The green power light should remain illuminated for >25 sec, if it does not, the 9V alkaline battery is depleted;
3) If the wand battery appears depleted, replace it with another 9V alkaline battery and attempt communication again. If communication is still unsuccessful, proceed to Step 4;
4) Verify that all connections between the wand and HHD cables are secure. If communication is still unsuccessful, proceed to Step 5;
5) Verify that the wand is directly over the generator, whose implant depth should be no greater than 1 inch, and that the wand is 3-4 feet away from any other electronic equipment. Rotate the wand 45 degrees and attempt communication again (slight pressure may be applied). If communication is still unsuccessful, proceed to Step 6;
6) Consider using alternative equipment. If communication is successful with other equipment, replace the product in question with known functional product (i.e. such as an alternate wand, serial adapter cable, etc) to isolate the suspect piece of equipment; If communication is still unsuccessful, proceed to Step 7;
7) For messages received upon attempted interrogation, consider other clinical symptoms that may suggest an EOS condition. A battery life calculation can be performed in order to evaluate the possible end of service condition of the generator (Note: Battery life calculations are not available for all generator models). Contact CTS for assistance.

Perform a generator reset:

1) Place a VNS Therapy Magnet and the Programming Wand over the Pulse Generator, and press down continuously on the two red “Reset” buttons for at least 30 seconds;
2) Wait an additional 30 seconds, then interrogate the Pulse Generator;
3) For models 100, 101, and 102/102R, reprogram the serial number, patient ID, and implant date. This step is not necessary for later models.
4) Reprogram the Pulse Generator to the desired parameters.

Perform the following high impedance troubleshooting steps in the OR:

1) Back out the setscrew(s), remove lead pin(s), and allow the hex screwdriver to remain engaged with the setscrew(s);
2) Verify that the setscrew(s) is not visible in the Lead receptacle(s);
3) Insert Lead connector pin(s) and tighten setscrew(s) until the hex screwdriver clicks;
4) Visually inspect the Lead receptacle(s) and verify that the Lead pin(s) is past the back end of the connector block;
5) For model 102 and 103, ensure the end of connector ring is inside of Lead receptacle;
6) Tighten setscrew(s) until the hex screwdriver clicks
7) For initial implant only: If nerve site is dry, irrigate the nerve and remove pooled fluid;
8) Retry System Diagnostics.

If high impedance resolves, continue with implant; otherwise:
1) Back out setscrew(s) and remove Lead pin(s);
2) Insert test resistor into Pulse Generator and tighten setscrew(s) with hex screwdriver until the screwdriver clicks;
3) Perform Generator Diagnostics.

If a high impedance is detected while performing the generator test, there may be a generator issue; otherwise:
1) Back out the setscrew(s) and remove the test resistor;
2) Verify the setscrew(s) is not visible in the Lead receptacle(s);
3) Insert the hex screwdriver, through the generator septum, so that it properly engages with the setscrew(s);
4) Insert connector pin(s) and visually insepct the Lead receptacle(s) in order to verify that the Lead pin(s) is past the back end of the connector block
5) Tighten setscrew(s) until the hex screwdriver clicks;
6) Retry System Diagnostics.

If high impedance resolves, continue with implant; otherwise, there may be a lead issue (eg. lead fracture, fibrosis, etc.) and a lead revision may be appropriate. Contact CTS for assistance.

Perform the following high impedance troubleshooting when detected outside of the OR (e.g. clinic setting):

1) Perform System Diagnostics and record results;
– DCDC codes 0-3: no intervention is needed. Consider re-running System Diagnostics to confirm result. Exception: DCDC code of 0, or a sudden drop in DCDC code from previous baseline (i.e. from 3 to a 0), accompanied with clinicals symptoms such as pain, increased seizures, etc. may indicate the presence of a possible short circuit condition; in those cases further assessment is required and surgical intervention may be needed.
– DCDC codes 4-7: there is likely an issue with the continuity of the system, such as fibrosis, lead fracture, lead pin’s not being fully inserted, etc. Surgical intervention is likely required. Device disablement (output current programmed to 0 mA) is recommended. Contact CTS for further assistance.

2) Perform Normal Mode Diagnostics and records results;
– DCDC codes 0-6 or 7 with Output Status “OK”: no intervention is needed. Consider re-running Normal Mode Diagnostics to confirm result;
– DCDC code 7 and Output Status “LIMIT”: If observed with DCDC codes of 4-7 on System Diagnostics, there is likely an issue with the continuity of the system and
surgical intervention is likely required. If observed with DCDC codes of 0-3 on System Diagnostics, the Generator cannot deliver the programmed output current. Consider
reducing output current or pulse width.

Perform the following troubleshooting steps when high impedance is detected outside of the OR (e.g. clinic setting):

1) Perform System or Normal Mode Diagnostics and record results;
– Impedance values =7000 Ohms: there is likely an issue with the continuity of the system, such as fibrosis, lead fracture, lead pin(s) not fully inserted, etc. and
surgical intervention is likely required. Device disablement (output current programmed to 0 mA) is recommended. Contact CTS for further assistance.

The latest update of parameter or diagnostic data present on the Flashcard is more recent than the HHD
(NOTE: THIS DOES NOT MEAN THERE IS NECESSARILY MORE DATA ON THE FLASHCARD):

1) Verify that the current Flashcard is the backup source normally used with the current HHD;
– If it is not, inset the correct Flashcard into the HHD. If writing to a Flashcard from a different operating system is continued, the software will present an SQL error.
– If it is, do not proceed with Backing up to Flashcard and proceed to Step 2 if it is desired to keep the more recent data;
2) Consider copying the Flashcard data by performing the following, then proceed to Step 3:
– Using a blank Flashcard, or…
– Send the current Flashcard back to Cyberonics where the information can be downloaded. An Excel sheet of the Flashcard can be sent back to the user;
3) Continue with the Back up to Flashcard operation if desired.

The latest update of parameter or diagnostic data present on the HHD is more recent than the Flashcard
(NOTE: THIS DOES NOT MEAN THERE IS NECESSARILY MORE DATA ON THE HHD):

1) Verify that the current Flashcard is the backup source normally used with the current HHD;
– If it is not, insert the correct Flashcard into the HHD. If writing to a Flashcard from a different operating system is continued, the software will present an SQL error.
– If it is, proceed to Step 2;
2) The current Flashcard has been removed from the HHD during interrogations or diagnostic tests OR the data on the Flashcard has been deleted. Cancel the Restore from
Flashcard operation if the HHD data information is to be preserved.

If the reason states “a wand reset”:

1) Proceed with interrogation and input the correct generator information (e.g. patient initials, generator serial number, implant date) for pre-demipulse models;
2) Reprogram the generator to desired settings.

If the reason states “Vbat < EOS threshold”:

1) If the event is believed to be related to EOS, replacing the generator is recommended if the continuation of VNS therapy is desired;
2) If the event is not believed to be related to EOS , contact CTS for additional information.

If the reason is not “a wand reset” or “Vbat < EOS threshold”:
1) Obtain copy of all relevant Flashcard data;
2) Notify Clinical Technical Services (CTS).

If in the OR and during an initial implant:
1) Remove any excess liquid that may have pooled around the leads;
2) Repeat diagnostics;
3) If problem persists, contact CTS as there may be a lead issue and lead replacement may be necessary.

All other cases:
1) Repeat diagnostics testing to verify result;
2) If problem persists, contact CTS as there may be a lead issue and lead replacement may be necessary.

Contact CTS for further information.

If the generator was part of a clinical or other study:
1) Use the corresponding software to program the device as desired;

If the generator was not part of a clinical or other study:
1) Proceed with programming the generator to correct the setting if desired;
2) Obtain information on where the patient was seen in the past and obtain any relevant Flashcard data if possible.

The Flashcard serves as a data backup for the VNS Therapy System. If the Flashcard is removed, data from the HHD will not be transferred to it. Consequently, the Flashcard may not contain all of the HHD’s information once it is replaced if HHD operations are performed with the Flashcard removed.
(NOTE: It is not possible to run V8.0 VNS software without a VNS Flashcard in the HHD)

1) If the user does not have a VNS Flashcard, arrange for a new one to be sent;
2) If the user does have a VNS Flashcard, reinsert it and proceed with session.