Application & User Guide

About TAC-STIM

TAC-STIM™, non-invasive Vagus Nerve Stimulator (nVNS) is a Low-Risk General Wellness Product. The product has not been reviewed by the FDA and is not intended to treat or diagnose any medical condition or disease.

TAC-STIM (nVNS) delivers proprietary electrical signals via two small electrodes placed on the skin at the cervical level. The electrical energy stimulates the vagus nerve, which triggers neurotransmitters in the brain.

NOTE: TAC-STIM is active for 36 months when turned on, and the session intensity increased past three.

Get to know TAC-STIM

Tac-stim information

The icons below indicate what the number on the display represents.

Months remaining

Months remaining

Intensity level

Intensity level

Sessions remaining in a 24-hour period

Sessions remaining in a 24-hour period

Charging TAC-STIM

  • Plug the charging cord into the back of the charging case and connect it to an electrical outlet.
  • Place TAC-STIM into the charging case.
  • “Ch” will appear on the display, indicating it is placed correctly and charging.
  • Charge TAC-STIM for at least one hour prior to first use.

Cleaning TAC-STIM

  • Clean TAC-STIM after each use by gently wiping the case and the stimulation surfaces with a soft, dry cloth to remove leftover gel.
  • Put the cap back on the product after use to protect the stimulation surfaces from dirt, debris, and damage.

Using TAC-STIM

26 additional sessions available for use as needed.

1. Locate your vagus nerve.

  1. Use 2 fingers to locate your pulse in the cervical region; the vagus nerve is in the same area.
  2. Make sure the application site is clean and dry.
  3. Remove anything blocking the application site
Locate your vagus nerve

2. Prepare your TAC-STIM.

  1. Remove the cap.
  2. Apply a pea-sized amount of the provided gel to the stimulation surfaces.
      1. Not applying the gel as described may cause the session to be uncomfortable or less effective.
  3. Turn TAC-STIM on by pressing the power button. When TAC-STIM is ready for use, it will beep once

3. Administer the sessions.

  1. Place TAC-STIM over the vagus nerve at the cervical region.
  2. Increase the intensity level until you notice a slight muscle contraction at the corner of your mouth.
  3. TAC-STIM will stop automatically after 2 minutes.

NOTE: You will likely feel muscle contractions at the application site and may experience a lip pull. These are normal and should stop after the session is complete. If muscle contractions are too strong or uncomfortable, try:

  • Lowering the intensity level by pressing the bottom area of the control button.
  • Repositioning the electrodes on the neck over the pulse and slowly increasing the intensity level again by pressing the top area of the control button.

If the intensity level is still too strong, stop the session and turn TAC-STIM off by pressing and holding the power button for 3 seconds.

NOTE: Additional gel may be needed between sessions.

For more assistance, visit tac-stim.com or call 888-901-7846.

Administer the sessions.

Warnings and Precautions

icon

WARNINGS

Do not use TAC-STIM if:

  • You have an active implantable medical device, such as a pacemaker, hearing aid implant, or any implanted electronic product.
  • You are using another product at the same time (e.g., TENS Unit, muscle stimulator).
  • You are driving, operating machinery, or during any activity that may put the user at risk of injury.
  • You are in the presence of strong electromagnetic fields, such as MRI scanners.
  • You are in an explosive atmosphere or in the presence of flammable gas mixtures.
  • You have an open wound, rash, infection, swelling, cut, sore, drug patch, or surgical scar(s) on the neck at the application site.
  • You have wet skin, are in the water, or just stepped out of the water (e.g., shower, bath, pool).

There is no data on the use of TAC-STIM in the following cases:

  • If you have had surgery to cut the vagus nerve at the neck as it may not be effective.
  • If you are younger than 12.
  • If you are pregnant or breastfeeding.
  • More than 24 times a day.
icon

PRECAUTIONS

  • TAC-STIM should only be used as described in the User Guide.
  • Only use a TAC-STIM-supplied conductive gel.
  • Do not apply TAC-STIM across or through the head, directly on the eyes, covering the mouth, on the chest, on the upper back, or over the heart.
  • Do not use TAC-STIM if there are signs of damage or defects.
  • Do not use if an error code is displayed on the screen when the product is turned on.
  • Do not submerge TAC-STIM in water; it is not water resistant.
  • Store in a safe location out of reach of children.

Integrated Safety Summary

In the Integrated Safety data from all controlled studies using nVNS (n-1205), there are no adverse events reported in greater than > 5% of subjects. The table below lists the most commonly reported adverse events reported in >1% of subjects.

Adverse EventAdverse Event

Frequency

Application site discomfortApplication site discomfort

4.3%

Application site irritation/rednessApplication site irritation/redness

3.4%

HeadacheHeadache

2.8%

Local pain, face/head/neck area (including toothache)Local pain, face/head/neck area (including toothache)

2.7%

Muscle twitching and/or contractionsMuscle twitching and/or contractions

2.4%

DizzinessDizziness

1.9%

Tingling, pricking or a feeling of “pins and needles” on the skin where the unit is appliedTingling, pricking or a feeling of “pins and needles” on the skin where the unit is applied

1.6%

The adverse events are reported to be mild and transient in nature and typically resolve when the use of the device is completed.

Troubleshooting

TAC-STIM does not turn on

  • TAC-STIM is not charged. Charge TAC-STIM by placing it in the charging case.
  • Restart TAC-STIM by pressing and holding the power button for 3 seconds.

TAC-STIM does not charge

  • If “Un” is displayed, remove and place back in charging case. If “Un” continues to be displayed, move product around in the charging case.
  • Ensure the AC power cord is plugged into a live power outlet and into the charging case. Only use the provided AC power cord with the charging case.

TAC-STIM displays an error code

  • Contact the TAC-STIM Customer Experience Team.

TAC-STIM Disposal

Regulations require that the disposal of electrical and electronic equipment is handled in a controlled manner. A product that may be contaminated after use or contain chemicals or elements that may present hazards to people, or the environment must be disposed of in accordance with the applicable government regulations. Contact the TAC-STIM Customer Experience Team if you have questions about the appropriate disposal of this product.

 

NOTE: TAC-STIM contains lithium batteries that the user cannot remove.

NOTE: Please dispose of TAC-STIM like a cell phone or other electronic product. Check with your local municipality to do this according to your local electronic waste regulations.

Symbols and Nomenclature Description

Handling TAC-STIM

Operating Conditions (TAC-STIM Product)

  • Range: -40°F to 140°F (-20°C to 60°C).
  • Maximum Output: 30V (peak), 60mA (peak).
  • Load Impedance: 450 to 550 Ohms.
  • TAC-STIM produces an electrical signal consisting of five 5,000-Hz pulses, repeating at a rate of 25 Hz. The waveform of the TAC-STIM pulse is approximately a sine wave.

Operating Conditions (Charging Case)

  • Range: -40°F to 140°F (-20°C to 60°C).
  • Only use the charging case indoors.
  • Do not place any object except TAC-STIM on the charging surface.
  • Maximum Output: 5.5V DC, 5W.
  • Input: 100 to 240 VAC, 50 to 60 Hz, 0.4A max.
  • The expiration date of the conductive gel is 5 years after the date of manufacture.

Storage/Transport Conditions

  • TAC-STIM should be stored at room temperature away from moisture.
  • Range: 32°F to 100°F (0°C to 38°C).
  • Replace cap after each use.
  • Store TAC-STIM in such a way (e.g., drawer or shelf) that the cap remains in place and is not accidentally removed.

Service Life

  • The service life of TAC-STIM is 3 years after the date the product has been activated.

Electrical Classification

Electrical Classification (TAC-STIM Product)

  • UL 60601-1 Class III; EN 60601-1 Internally Powered Equipment.
  • Type BF Applied part.
  • IP22 Protected against ingress of solid foreign objects ≥ 12.5 mm diameter and protected against vertically falling water drops when enclosure tilted up to 15°.
  • Product contains Bluetooth RF transmitter: Frequency range of 2.379 to 2.496 GHz, GFSK Modulation, 1mW max power.

Electrical Classification (Charging Case)

  • UL 60601-1 Class III.
  • Accessible Part.
  • IP22 protected against ingress of solid foreign objects ≥ 12.5 mm diameter and protected against vertically falling water drops when enclosure tilted up to 15°.

Electromagnetic Compatibility Guidance

All engineering specifications have passed the required test levels. All specifications are available upon request.

Contact Information

Customer Experience Team:

E-mail: support@tac-stim.com
electroCore, Inc.
200 Forge Way, Suite 205
Rockaway, NJ 07866
United States
Telephone: 888-901-7846

Manufacturer:

E-mail: support@tac-stim.com
electroCore, Inc.
200 Forge Way, Suite 205
Rockaway, NJ 07866
United States
Telephone: 888-901-7846

Product Complaint Reports and/or related issues may be submitted directly to electroCore, Inc.:
Telephone: +1 (973) 355-6708
E-mail: complaints@electrocore.com

©2023 electroCore, Inc. All rights reserved. electroCore, the electroCore logo, TAC-STIM, and the TAC-STIM logo are trademarks of electroCore, Inc. For patent information, please visit electroCore.com electroCore software or firmware, or any updates or later versions thereof, included in or provided for use with any electroCore product is provided subject to a revocable, non-exclusive license solely for use with such electroCore product to operate such product for its intended use, and not for any other use, and may not be copied, altered, removed, modified, reprogrammed, de-compiled or used for any other purpose. Any attempt to access, copy, remove, modify, reprogram, de-compile, or otherwise use any software licensed hereunder in any manner inconsistent with this license grant shall entitle electroCore to terminate the license.

Customer Service Limited Liability: electroCore guarantees against any out-of-box failures and warrants that the Products shall meet the Product Standard. The warranty does not apply to any Product that: (i) has been subjected to abuse, misuse, neglect, negligence, accident, improper testing, improper installation, improper storage, improper handling, abnormal physical stress, abnormal environmental conditions, or use contrary to any instructions issued by electroCore; or (ii) has been reconstructed, repaired, or altered by persons other than electroCore or its authorized Representative. Customers shall not service, repair, modify, alter, replace, reverse engineer, or otherwise change any Products.